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


Phase 1
18 Years
45 Years
Not Enrolling
Male
Cytomegalovirus

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Trial Information

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


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Anti-Glycoprotein B (anti-gB) antibody concentrations by enzyme-linked immunosorbent assay (ELISA) in all subjects

Outcome Description:

Month 48 for all subjects of vaccine group. Month 60 for all subjects.

Outcome Time Frame:

Month 48 and Month 60

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

115429

NCT ID:

NCT01357915

Start Date:

June 2011

Completion Date:

September 2012

Related Keywords:

  • Cytomegalovirus
  • Cytomegalovirus
  • Vaccine

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