Viewing Study NCT00435812

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Ignite Creation Date: 2025-12-26 @ 10:19 PM
Ignite Modification Date: 2025-12-26 @ 10:19 PM
Study NCT ID: NCT00435812
Status: COMPLETED
Last Update Posted: 2019-03-20
First Post: 2007-02-13
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006505', 'term': 'Hepatitis'}], '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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'C075654', 'term': 'Engerix-B'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '510-848-5100', 'title': 'Robert Janssen MD \\ VP & Chief Medical Officer', 'organization': 'Dynavax Technologies, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events were assessed for safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data', 'eventGroups': [{'id': 'EG000', 'title': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24', 'otherNumAtRisk': 1821, 'otherNumAffected': 602, 'seriousNumAtRisk': 1821, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24', 'otherNumAtRisk': 607, 'otherNumAffected': 191, 'seriousNumAtRisk': 607, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 303}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 100}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Salpingo-oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Guillain-barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Delirium tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Granulomatosis with polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1821, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 607, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Seroprotective Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1520', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'OG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 for HEPLISAV and Week 28 for Engerix-B', 'description': 'Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population: Subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges, and had serology at their primary endpoint (Week 12 for HEPLISAV group and Week 28 for Engerix-B group)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Local and Systemic Reactions to Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1821', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'OG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24'}], 'classes': [{'title': 'Local Reaction : Injection 1', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}]}]}, {'title': 'Local Reaction : Injection 2', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}, {'value': '24.8', 'groupId': 'OG001'}]}]}, {'title': 'Local Reaction : Injection 3', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Reaction : Injection 1', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Reaction : Injection 2', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Reaction : Injection 3', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days post-injection for Post Injection Reactions', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0 and Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'FG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1820'}, {'groupId': 'FG001', 'numSubjects': '608'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1757'}, {'groupId': 'FG001', 'numSubjects': '590'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1821', 'groupId': 'BG000'}, {'value': '607', 'groupId': 'BG001'}, {'value': '2428', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'BG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '11 to 17 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '≥18 and ≤ 55 years', 'categories': [{'measurements': [{'value': '1810', 'groupId': 'BG000'}, {'value': '605', 'groupId': 'BG001'}, {'value': '2415', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '959', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '862', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '1123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1123', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '1489', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '698', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '939', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline safety data.\n\nNOTE: One (1) subject randomized to the Engerix-B group received HEPLISAV in error and was analyzed in the HEPLSAV group for the Safety Analysis Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2014-06-16', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2007-02-13', 'dispFirstSubmitQcDate': '2014-06-16', 'resultsFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2007-02-14', 'dispFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-15', 'studyFirstPostDateStruct': {'date': '2007-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Seroprotective Immune Response', 'timeFrame': 'Week 12 for HEPLISAV and Week 28 for Engerix-B', 'description': 'Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Local and Systemic Reactions to Injections', 'timeFrame': 'Within 7 days post-injection for Post Injection Reactions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HBV vaccine', 'Hepatitis B vaccine', 'Hepatitis B', 'Hepatitis', 'HBV', 'Immunostimulatory sequence (ISS)'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dynavax.com', 'label': 'Dynavax Webpage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.', 'detailedDescription': 'This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.\n\nComparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give written informed consent\n* Is serum negative for HBV antibodies\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Any previous HBV infection\n* Previous vaccination with any HBV vaccine (1 or more doses)\n* Any autoimmune disease\n* Received any blood products or antibodies within 3 months prior to study entry\n* Ever received an injection with DNA plasmids or oligonucleotides\n* Received any vaccines within 4 weeks prior to study entry\n* Received any other investigational medicinal agent within 4 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT00435812', 'briefTitle': 'Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynavax Technologies Corporation'}, 'officialTitle': 'A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®', 'orgStudyIdInfo': {'id': 'DV2-HBV-10'}, 'secondaryIdInfos': [{'id': '2006-006743-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEPLISAV and/or Placebo', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)', 'interventionNames': ['Biological: HEPLISAV and/or Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Engerix-B', 'description': '1.0 mL Engerix-B', 'interventionNames': ['Biological: Engerix-B']}], 'interventions': [{'name': 'HEPLISAV and/or Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['HEPLISAV', 'Hepatitis B vaccine (recombinant), adjuvanted'], 'description': 'Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24', 'armGroupLabels': ['HEPLISAV and/or Placebo']}, {'name': 'Engerix-B', 'type': 'BIOLOGICAL', 'otherNames': ['Hepatitis B vaccine (recombinant)'], 'description': 'Intramuscular (IM) injections on Week 0, Week 4, and Week 24', 'armGroupLabels': ['Engerix-B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Mount Pearl', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'geoPoint': {'lat': 47.51659, 'lon': -52.78135}}, {'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Leipzig', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Magdeburg', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'J. Tyler Martin, Sr, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dynavax Technologies Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynavax Technologies Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}