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Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals’ EBV (Epstein Barr Virus) Vaccine (268664).

This study has been completed.
Sponsor:
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00430534
First received: February 1, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Epstein Barr Virus (EBV) Infection
 Biological: EBV vaccine (268664)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henogen:

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)

Estimated Enrollment: 200
  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430534

Locations
Belgium
GSK Clinical Trials Call Center
Brussels, Belgium, 1200
Sponsors and Collaborators
Henogen
Investigators
Study Director: Clinical Trials Henogen
  More Information

No publications provided by Henogen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00430534     History of Changes
Other Study ID Numbers: HN/P001-EBV-003
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: Belgium: Institutional Review Board

Keywords provided by Henogen:
Epstein Barr Virus
Belgium
Infectious mononucleosis

ClinicalTrials.gov processed this record on May 21, 2013