- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430534
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
February 1, 2007 updated by: Henogen
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1200
- GSK Clinical Trials Call Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Attack rates of infectious mononucleosis over 18 months after Dose 2
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Secondary Outcome Measures
Outcome Measure |
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Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Henogen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 1, 2007
First Submitted That Met QC Criteria
February 1, 2007
First Posted (Estimate)
February 2, 2007
Study Record Updates
Last Update Posted (Estimate)
February 2, 2007
Last Update Submitted That Met QC Criteria
February 1, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN/P001-EBV-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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