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Completed

NCT Number: NCT00430534

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

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.

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Key information

Conditions

Epstein Barr Virus (EBV) Infection DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Infectious Mononucleosis Leukocyte Disorders Lymphatic Diseases Lymphoproliferative Disorders Tumor Virus Infections Virus Diseases

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Clinical Trials Call Center

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EBV vaccine (268664)

Biological

Primary outcomes

  1. Attack rates of infectious mononucleosis over 18 months after Dose 2

Secondary outcomes

  1. Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)

Sponsors and collaborators

Lead sponsor

Henogen

Industry

Registry information

Official study 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.

Important dates

First posted
Feb 2, 2007
Registry last updated
Feb 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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