At a glance
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A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
In Brief
A clinical study evaluating Blood sampling and GSK149203A for Infections, Cytomegalovirus. Completed, enrolled 47 participants across 2 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
Blood samples will be collected at 2 time points: At the long-term follow-up at approximately Month 48 of study (= ± 42 months post dose 3) from all subjects in the vaccine group. At the long-term follow-up at approximately Month 60 of study (= ± 54 months post dose 3) from all subjects.
GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses