Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT00698906
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2008-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-06-16', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HBs antibody concentrations', 'timeFrame': 'Month 7'}], 'secondaryOutcomes': [{'measure': 'Anti-HBs antibody concentrations', 'timeFrame': 'Month 1, 2 and 6'}, {'measure': 'Occurrence, intensity and relationship to vaccination of solicited local and general symptoms', 'timeFrame': '4-day follow-up after vaccination'}, {'measure': 'Occurrence, intensity and relationship to vaccination of unsolicited symptoms', 'timeFrame': '31-day follow-up after vaccination'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': 'During the study period'}]}, 'conditionsModule': {'keywords': ['Hepatitis B', 'HBV-MPL', 'Recombinant Hepatitis B vaccine'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months', 'detailedDescription': 'At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: between 19 and 40 years old.\n* Good physical condition as established by clinical examination and history taking at the time of entry.\n* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.\n* Written informed consent obtained from the subjects\n\nExclusion Criteria:\n\n* Positive titres at screening for anti-hepatitis antibodies.\n* Elevated serum liver enzymes.\n* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.\n* Any acute disease at the moment of entry.\n* Chronic alcohol consumption.\n* Hepatomegaly, right upper quadrant abdominal pain or tenderness.\n* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.\n* History of allergic disease likely to be stimulated by any component of the vaccine.\n* Simultaneous participation in any other clinical trial.\n* Previous vaccination with a hepatitis B vaccine.\n* Previous vaccination with an MPL containing vaccine.\n* Administration of immunoglobulins in the past 3 months and during the whole study period\n* Vaccination one month before and one month after each dose of the study vaccine"}, 'identificationModule': {'nctId': 'NCT00698906', 'briefTitle': 'Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 19-40 Years", 'orgStudyIdInfo': {'id': '208129/026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Biological: HBV-MPL vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Biological: HBV-MPL vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Biological: HBV-MPL vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'interventionNames': ['Biological: HBV-MPL vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group E', 'interventionNames': ['Biological: HBV-MPL vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group F', 'interventionNames': ['Biological: Engerix™-B']}], 'interventions': [{'name': 'HBV-MPL vaccine', 'type': 'BIOLOGICAL', 'description': '5 different formulations, 2-dose intramuscular injection', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E']}, {'name': 'Engerix™-B', 'type': 'BIOLOGICAL', 'description': '3-dose intramuscular injection', 'armGroupLabels': ['Group F']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Isabelle Harpigny', 'oldOrganization': 'GSK'}}}}