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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014