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

Launched by GLAXOSMITHKLINE · May 19, 2011

Keywords

ClinConnect Summary

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 ...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
• • Written informed consent obtained from the subject.
• • Healthy subjects as established by clinical evaluation (medical history and physical examination) before entering in the study.
• 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:
• • Use, or planned use, of any investigational or non-registered product (drug or vaccine) during the study period.
• • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study visit(s). For corticosteroids, this will mean prednisone, 20mg/day, or equivalent. Inhaled and topical steroids are allowed.
• • Administration of immunoglobulins and/or any blood products within three months preceding study visit(s).
• • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• 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).