Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
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.
1 other identifier
interventional
200
1 country
1
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 placebo during the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedFebruary 2, 2007
February 1, 2007
February 1, 2007
February 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attack rates of infectious mononucleosis over 18 months after Dose 2
Secondary Outcomes (1)
Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henogenlead
Study Sites (1)
GSK Clinical Trials Call Center
Brussels, 1200, Belgium
Related Publications (1)
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.
PMID: 18190254DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Henogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Last Updated
February 2, 2007
Record last verified: 2007-02