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

Henogen

Status and phase

Completed

Phase 2

Conditions

Epstein Barr Virus (EBV) Infection

Treatments

Biological: EBV vaccine (268664)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00430534

HN/P001-EBV-003

Details and patient eligibility

About

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.

Sex

All

Ages

16 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.