Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

Study Overview
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Brief Summary
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To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period.

Official Title
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To Evaluate the Safety, Immunogenicity and Efficacy of GSK Biologicals' EBV Vaccine (268664) in Healthy Seronegative Adolescents/Adults When Injected Intramuscularly According to a 0-1-5 Month Schedule in Belgium.

Conditions
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Epstein Barr Virus (EBV) Infection

Intervention / Treatment
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* Biological: EBV vaccine (268664)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening. Written informed consent obtained from the subject prior to enrolment. Seronegative for EBV antibody. Exclusion Criteria: Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. History of intravenous drug abuse within the past 2 years. Known or suspected allergy to any vaccine component.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: EBV vaccine (268664)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attack rates of infectious mononucleosis over 18 months after Dose 2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epstein Barr Virus, Belgium, Infectious mononucleosis