Epstein Barr Virus (EBV) Infection Clinical Trial
Official title:
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.
| NCT number | NCT00430534 |
| Other study ID # | HN/P001-EBV-003 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | February 1, 2007 |
| Last updated | February 1, 2007 |
| Verified date | February 2007 |
| Source | Henogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 16 Years to 25 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | GSK Clinical Trials Call Center | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Henogen |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Attack rates of infectious mononucleosis over 18 months after Dose 2 | |||
| Secondary | Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study) |