A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
During the long-term follow-up study, all subjects who received 3 doses of GSK Biologicals'
candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890
(NCT00435396) will be invited to participate at Visit 8 (Year 4) and Visit 9 (Year 5) as the
vaccine group. In addition, the healthy subjects who participated in the screening visit of
the primary study 108890 (NCT00435396) and who were tested CMV-seropositive will be invited
to Visit 9 (Year 5) of this study as the seropositive reference group.This Protocol Posting
has been updated following Protocol Amendment 1, March 2012, leading to the update of brief
summary, intervention model, enrolment, outcome measures, eligibility and arms.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Anti-Glycoprotein B (anti-gB) antibody concentrations by enzyme-linked immunosorbent assay (ELISA) in all subjects
Month 48 for all subjects of vaccine group. Month 60 for all subjects.
Month 48 and Month 60
GSK Clinical Trials
Belgium: Federal Agency for Medicinal Products and Health Products