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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV vaccine (268664) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Attack rates of infectious mononucleosis over 18 months after Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study) |
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Inclusion Criteria:
Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Henogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18190254 | Derived | Sokal EM, Hoppenbrouwers K, Vandermeulen C, Moutschen M, Leonard P, Moreels A, Haumont M, Bollen A, Smets F, Denis M. Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults. J Infect Dis. 2007 Dec 15;196(12):1749-53. doi: 10.1086/523813. |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D007239 | Infections |
| D007244 | Infectious Mononucleosis |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
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| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |