Status:
COMPLETED
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
Lead Sponsor:
Henogen
Conditions:
Epstein Barr Virus (EBV) Infection
Eligibility:
All Genders
16-25 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00430534
Last Update
February 2 2007
Active Locations (1)
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1
GSK Clinical Trials Call Center
Brussels, Belgium, 1200