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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

February 1, 2007
February 1, 2007
Not Provided
Not Provided
Attack rates of infectious mononucleosis over 18 months after Dose 2
Same as current
No Changes Posted
Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Epstein Barr Virus (EBV) Infection
Biological: EBV vaccine (268664)
Not Provided
Sokal EM, Hoppenbrouwers K, Vandermeulen C, Moutschen M, Léonard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
Not Provided

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.
Both
16 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00430534
HN/P001-EBV-003
Not Provided
Not Provided
Henogen
Not Provided
Study Director: Clinical Trials Henogen
Henogen
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP