Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 2:18 AM
Study NCT ID:
NCT02203357
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}], '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': {'email': 'zhuangbmu@126.com', 'phone': '86-10-82801617', 'title': 'Dr. Hui Zhuang', 'organization': 'Peking University Health Science Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.', 'otherNumAtRisk': 117, 'otherNumAffected': 2, 'seriousNumAtRisk': 117, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '60μg, 0-1', 'description': '111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.', 'otherNumAtRisk': 111, 'otherNumAffected': 2, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.', 'otherNumAtRisk': 125, 'otherNumAffected': 5, 'seriousNumAtRisk': 125, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.'}, {'id': 'OG001', 'title': '60μg, 0-1', 'description': '111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.'}, {'id': 'OG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1847.99', 'groupId': 'OG000', 'lowerLimit': '1417.75', 'upperLimit': '2408.8'}, {'value': '839.27', 'groupId': 'OG001', 'lowerLimit': '507.34', 'upperLimit': '1388.35'}, {'value': '1244.8', 'groupId': 'OG002', 'lowerLimit': '889.61', 'upperLimit': '1742.21'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after a series vaccination of the regimen', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs antibody will be compared among the three vaccine groups.', 'unitOfMeasure': 'mIU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG001', 'title': '60μg, 0-1', 'description': '111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}], 'classes': [{'categories': [{'measurements': [{'value': '1456.63', 'groupId': 'OG000', 'lowerLimit': '1102.78', 'upperLimit': '1924.00'}, {'value': '256.30', 'groupId': 'OG001', 'lowerLimit': '175.70', 'upperLimit': '373.85'}, {'value': '235.15', 'groupId': 'OG002', 'lowerLimit': '172.81', 'upperLimit': '319.96'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1-year after the first dose of the regimens', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs will be compared among the three vaccine groups.', 'unitOfMeasure': 'mIU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG001', 'title': '60μg, 0-1', 'description': '111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}], 'classes': [{'categories': [{'measurements': [{'value': '427.46', 'groupId': 'OG000', 'lowerLimit': '274.92', 'upperLimit': '664.51'}, {'value': '89.74', 'groupId': 'OG001', 'lowerLimit': '50.43', 'upperLimit': '159.70'}, {'value': '89.80', 'groupId': 'OG002', 'lowerLimit': '56.96', 'upperLimit': '141.58'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2-year after the first dose of the regimens', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.', 'unitOfMeasure': 'mIU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety of HBV Vaccine Determined by Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG001', 'title': '60μg, 0-1', 'description': '111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}, {'id': 'OG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.\n\nHepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 day after the first dose of immunization', 'description': 'Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.'}, {'id': 'FG001', 'title': '60μg, 0-1', 'description': '111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.'}, {'id': 'FG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'mon7/2/3', 'comment': 'mon 7 for 0-1-6 group, mon 2 for 0-1 group, mon 3 for 0-2 group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'mon12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'mon24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '70'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.'}, {'id': 'BG001', 'title': '60μg, 0-1', 'description': '111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.'}, {'id': 'BG002', 'title': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.32', 'spread': '1.13', 'groupId': 'BG000'}, {'value': '20.11', 'spread': '0.94', 'groupId': 'BG001'}, {'value': '20.18', 'spread': '1.07', 'groupId': 'BG002'}, {'value': '20.20', 'spread': '1.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2014-07-18', 'resultsFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2014-07-27', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-09', 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of HBV Vaccine Determined by Number of Participants With Adverse Events', 'timeFrame': '0-3 day after the first dose of immunization', 'description': 'Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.'}], 'primaryOutcomes': [{'measure': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'timeFrame': 'one month after a series vaccination of the regimen', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs antibody will be compared among the three vaccine groups.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'timeFrame': '1-year after the first dose of the regimens', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs will be compared among the three vaccine groups.'}, {'measure': 'Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults', 'timeFrame': '2-year after the first dose of the regimens', 'description': 'The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \\< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \\< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.\n\nThe GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.'}]}, 'conditionsModule': {'keywords': ['hepatitis B', 'hepatitis B vaccine', 'immunogenicity', 'adults'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '26801063', 'type': 'DERIVED', 'citation': 'Wang ZZ, Li MQ, Wang P, Yang ZX, Wei L, Zeng Y, Li YP, Yan L, Liu XE, Zhuang H. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China. Vaccine. 2016 Feb 17;34(8):1034-9. doi: 10.1016/j.vaccine.2016.01.018. Epub 2016 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged between 16 and 25 as established by medical history and clinical examination\n* Written informed consent will be obtained from each subject before the serum screening of HBV markers\n* Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody\n* Have never been immunized with HBV vaccine before\n\nExclusion Criteria:\n\n* Subject has a medical history of allergic to any ingredient of vaccine\n* Family history of seizures or progressive neurological disease\n* Autoimmune disease or immunodeficiency\n* Women with pregnant\n* Bleeding disorder diagnosed by a doctor\n* Chronic diseases: hepatitis, tumor, tuberculosis,et.al\n* Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment\n* Subjects had a medical history of serious adverse reactions to vaccines'}, 'identificationModule': {'nctId': 'NCT02203357', 'briefTitle': 'A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults', 'orgStudyIdInfo': {'id': 'HepB-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20μg, 0-1-6', 'description': '117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.', 'interventionNames': ['Biological: Hepatitis B vaccine']}, {'type': 'EXPERIMENTAL', 'label': '60μg, 0-1', 'description': '112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.', 'interventionNames': ['Biological: Hepatitis B vaccine']}, {'type': 'EXPERIMENTAL', 'label': '60μg, 0-2', 'description': '125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.', 'interventionNames': ['Biological: Hepatitis B vaccine']}], 'interventions': [{'name': 'Hepatitis B vaccine', 'type': 'BIOLOGICAL', 'description': 'Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.', 'armGroupLabels': ['20μg, 0-1-6', '60μg, 0-1', '60μg, 0-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhongliao Fang, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangxi provincial center for desease control and prevention'}, {'name': 'Hui Zhuang, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangxi Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'Liuzhou City Center for disease control and prevention', 'class': 'UNKNOWN'}, {'name': 'Shenzhen Kangtai Biological Products Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Xueen Liu', 'investigatorAffiliation': 'Peking University'}}}}