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About
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).
Full description
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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Inclusion criteria
Subjects of the vaccine group should in addition satisfy the following criterion:
• Subjects who participated in the primary study 108890 (NCT00435396), having received 3 doses of the GSK's CMV candidate vaccine and having completed the Year 2 follow-up study 109211 (NCT00435396).
Subjects of the seropositive reference group should in addition satisfy the following criterion:
• Subjects who participated in the screening visit of the primary study 108890 (NCT00435396), and whose blood sample taken at this visit was tested CMV positive.
Exclusion criteria
For subjects in the vaccine group, the following exclusion criterion should be checked in addition:
• Administration of any additional CMV vaccine since end of primary study 108890 (NCT00435396).
For subjects in the seropositive reference group, the following exclusion criterion should be checked in addition:
• Administration of any CMV vaccine since the screening visit of primary study 108890 (NCT00435396).
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47 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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