Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-31 @ 1:31 AM
Study NCT ID:
NCT00697866
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2008-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia', 'France', 'Italy', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 951}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2008-06-12', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HBs antibody concentrations', 'timeFrame': 'At month 3'}], 'secondaryOutcomes': [{'measure': 'Anti-HBs antibody concentrations', 'timeFrame': 'At M1, M2, M3'}, {'measure': 'Anti-RF1 antibody titres in a subset of 50 subjects per group', 'timeFrame': 'At months 0 and 3'}, {'measure': 'Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms', 'timeFrame': 'During a 4-day follow-up after vaccination'}, {'measure': 'Occurrence, intensity and relationship to vaccination of unsolicited symptoms', 'timeFrame': 'Within 30 days after each vaccination'}, {'measure': 'Occurrence, intensity and relationship to vaccination of serious adverse events', 'timeFrame': 'During the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adjuvanted hepatitis B vaccine', 'Hepatitis B', 'Recombinant hepatitis B vaccine'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'availIpds': [{'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '208129/037', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.', 'detailedDescription': 'Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.\n\nAt the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).\n* Previous vaccination against hepatitis B\n* History of non-response to previous hepatitis B vaccination\n* Known exposure to hepatitis B within the previous 6 weeks\n* History of hepatitis B infection\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* A family history of congenital or hereditary immunodeficiency.\n* Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Acute disease at the time of enrolment.\n* Hepatomegaly, right upper quadrant abdominal pain or tenderness.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female'}, 'identificationModule': {'nctId': 'NCT00697866', 'briefTitle': 'Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Evaluating the Consistency of 3 Consecutive Lots of GSK Biologicals' Novel Adjuvanted HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as a Control, Administered According to a 0, 1, 2-month Schedule in Healthy Volunteers (15-50y).", 'orgStudyIdInfo': {'id': '208129/037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'HBV-MPL Lot A', 'interventionNames': ['Biological: HBV-MPL vaccine 208129']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'HBV-MPL Lot B', 'interventionNames': ['Biological: HBV-MPL vaccine 208129']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'HBV-MPL Lot C', 'interventionNames': ['Biological: HBV-MPL vaccine 208129']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Engerix™-B', 'interventionNames': ['Biological: Engerix™-B']}], 'interventions': [{'name': 'HBV-MPL vaccine 208129', 'type': 'BIOLOGICAL', 'description': '3 consecutive lots; 3-dose intramuscular injection', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Engerix™-B', 'type': 'BIOLOGICAL', 'otherNames': ['HBV-MPL vaccine 208129'], 'description': '3-dose intramuscular injection', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}