NCT01357915

Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine

A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Infections, Cytomegalovirus

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	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.
BIOLOGICAL	GSK149203A	GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses

Timeline

• Start date: 2011-06-24
• Primary completion: 2012-09-13
• Completion: 2012-09-13
• First posted: 2011-05-23
• Last updated: 2020-01-13
• Results posted: 2017-10-06

Locations

2 sites across 1 country: Belgium