Infections, Cytomegalovirus Clinical Trial
Official title:
A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
The purpose of this study is to evaluate the persistence of the vaccine induced immune
responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy 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) (vaccine group). The immune response to CMV infection in
naturally infected subjects who participated in the screening visit of the primary study
108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value
(seropositive reference group). In addition, this study will continue to assess the
occurrence of CMV infections as well as the continued development and validation of read-outs
in the CMV project.
The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting
(NCT00435396).
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. ;
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