Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT00430534
Status:
COMPLETED
Last Update Posted:
2007-02-02
First Post:
2007-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007244', 'term': 'Infectious Mononucleosis'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2007-02-01', 'studyFirstSubmitDate': '2007-02-01', 'studyFirstSubmitQcDate': '2007-02-01', 'lastUpdatePostDateStruct': {'date': '2007-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attack rates of infectious mononucleosis over 18 months after Dose 2'}], 'secondaryOutcomes': [{'measure': 'Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)'}]}, 'conditionsModule': {'keywords': ['Epstein Barr Virus', 'Belgium', 'Infectious mononucleosis'], 'conditions': ['Epstein Barr Virus (EBV) Infection']}, 'referencesModule': {'references': [{'pmid': '18190254', 'type': 'DERIVED', 'citation': 'Sokal EM, Hoppenbrouwers K, Vandermeulen C, Moutschen M, Leonard 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. doi: 10.1086/523813.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening.\n\n * Written informed consent obtained from the subject prior to enrolment.\n * Seronegative for EBV antibody.\n\nExclusion Criteria:\n\n* 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.\n\n * 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.\n * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n * Family history of congenital or hereditary immunodeficiency.\n * Major congenital defects or serious chronic illness.\n * History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.\n * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n * History of intravenous drug abuse within the past 2 years.\n * Known or suspected allergy to any vaccine component.'}, 'identificationModule': {'nctId': 'NCT00430534', 'briefTitle': "Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).", 'organization': {'class': 'INDUSTRY', 'fullName': 'Henogen'}, 'officialTitle': "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.", 'orgStudyIdInfo': {'id': 'HN/P001-EBV-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EBV vaccine (268664)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henogen', 'class': 'INDUSTRY'}}}}