Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
Primary Purpose
Epstein Barr Virus (EBV) Infection
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
EBV vaccine (268664)
Sponsored by
About this trial
This is an interventional prevention trial for Epstein Barr Virus (EBV) Infection focused on measuring Epstein Barr Virus, Belgium, Infectious mononucleosis
Eligibility Criteria
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.
Sites / Locations
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
Attack rates of infectious mononucleosis over 18 months after Dose 2
Secondary Outcome Measures
Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00430534
Brief Title
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Henogen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epstein Barr Virus (EBV) Infection
Keywords
Epstein Barr Virus, Belgium, Infectious mononucleosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
EBV vaccine (268664)
Primary Outcome Measure Information:
Title
Attack rates of infectious mononucleosis over 18 months after Dose 2
Secondary Outcome Measure Information:
Title
Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Henogen
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
18190254
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
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