Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00825305
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2009-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011818', 'term': 'Rabies'}], 'ancestors': [{'id': 'D018353', 'term': 'Rhabdoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegContactVacUS.nvdit@Novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Any unsolicited adverse events were collected for 7 days after each vaccination, all serious adverse events were collected throughout the whole study period (beyond individual study participation, from 12 Nov 2008 to 12 Jan 2009).', 'description': 'Subjects were instructed to report on a daily basis any adverse events and record them on a diary card.', 'eventGroups': [{'id': 'EG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.', 'otherNumAtRisk': 549, 'otherNumAffected': 52, 'seriousNumAtRisk': 549, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.', 'otherNumAtRisk': 275, 'otherNumAffected': 26, 'seriousNumAtRisk': 275, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'notes': 'Safety was analyzed for the safety set. One enrolled subject in the abbreviated Zaghreb group was not vaccinated and not included in the safety set, because of inappropriate inclusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 549, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Injury of soft tissue in the leg and shoulder', 'notes': 'Safety was analyzed for the safety set. One enrolled subject in the abbreviated Zaghreb group was not vaccinated and not included in the safety set, because of inappropriate inclusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody Concentrations on Day 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'OG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.73', 'upperLimit': '3.47'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.82', 'upperLimit': '3.79'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of log2 mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.4', 'estimateComment': 'Ratio of log2 mean (Zagreb/Essen) on day 14', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).'}], 'paramType': 'LOG_MEAN', 'timeFrame': '14 days', 'description': 'Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.'}, {'type': 'SECONDARY', 'title': 'Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'OG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}], 'classes': [{'title': 'day 7 results', 'categories': [{'measurements': [{'value': '-3.23', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '-2.86'}, {'value': '-3.02', 'groupId': 'OG001', 'lowerLimit': '-3.45', 'upperLimit': '-2.59'}]}]}, {'title': 'day 42 results', 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '3.80', 'upperLimit': '4.70'}, {'value': '4.32', 'groupId': 'OG001', 'lowerLimit': '3.84', 'upperLimit': '4.79'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of log2 mean (day7)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.35', 'estimateComment': 'Ratio of log2 means (Zagreb/Essen) on day 7', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of log2 mean (day 42)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.58', 'estimateComment': 'Ratio of log2 mean (Zagreb/(Essen) on day 42', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).'}], 'paramType': 'LOG_MEAN', 'timeFrame': '7 days and 42 days', 'description': 'Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.', 'unitOfMeasure': 'IU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'OG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}], 'classes': [{'title': 'Any local reaction', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': 'Any systemic reaction', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Fever ≥37.1°C', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after each vaccination', 'description': 'Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion.'}, {'type': 'SECONDARY', 'title': 'Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'OG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}], 'classes': [{'title': 'day 7', 'categories': [{'measurements': [{'value': '10.14', 'groupId': 'OG000', 'lowerLimit': '4.18', 'upperLimit': '19.79'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '19.52'}]}]}, {'title': 'day 14', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.79', 'upperLimit': '100'}, {'value': '97.14', 'groupId': 'OG001', 'lowerLimit': '90.19', 'upperLimit': '99.66'}]}]}, {'title': 'day 42', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.79', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '94.87', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days, 14 days and 42 days', 'description': 'Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.', 'unitOfMeasure': 'percentages of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'FG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '550'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '533'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Inappropriate inclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Can not be classified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in November 2008 at 1 center in China.', 'preAssignmentDetails': 'All enrolled subjects were randomized, but one subject in the Zagreb (2-1-1) group was not vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '824', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abbreviated Zagreb (2-1-1)', 'description': 'Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.'}, {'id': 'BG001', 'title': 'Conventional Essen(1-1-1-1-1)', 'description': 'Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '7.14', 'groupId': 'BG000'}, {'value': '39.33', 'spread': '6.93', 'groupId': 'BG001'}, {'value': '38.58', 'spread': '7.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures are presented for safety population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline measures are presented for safety population.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2009-01-19', 'resultsFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-20', 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rabies Virus Neutralizing Antibody Concentrations on Day 14.', 'timeFrame': '14 days', 'description': 'Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.'}, {'measure': 'Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination', 'timeFrame': '7 days after each vaccination', 'description': 'Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.'}], 'secondaryOutcomes': [{'measure': 'Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.', 'timeFrame': '7 days and 42 days', 'description': 'Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.'}, {'measure': 'Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.', 'timeFrame': '7 days, 14 days and 42 days', 'description': 'Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.'}]}, 'conditionsModule': {'keywords': ['vaccine', 'prevention', 'rabies', 'Rabies disease'], 'conditions': ['Rabies']}, 'referencesModule': {'references': [{'pmid': '25483635', 'type': 'DERIVED', 'citation': 'Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects 18-50 years of age who:\n* are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;\n* volunteer for the simulated post-exposure vaccination courses and blood draws;\n* have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;\n* are available for all the visits scheduled in the study.\n\nExclusion Criteria:\n\n* Subjects with the below criteria were excluded:\n* pregnancy or unwillingness to practice acceptable contraception during participation in the study;\n* a history of rabies immunization;\n* a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;\n* fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;\n* treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;\n* administration of any vaccine within the past 14 days before enrolment;\n* known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;\n* history of allergy to egg protein;\n* known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;\n* treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;\n* mental condition rendering the subject unable to understand the nature, scope and consequences of the study;\n* participation in any other investigational trial within the past 3 months before enrolment;\n* planned surgery during the study period;\n* intention to leave the area of the study site before the end of study period;\n* any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective."}, 'identificationModule': {'nctId': 'NCT00825305', 'briefTitle': 'Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China', 'orgStudyIdInfo': {'id': 'M49P8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zagreb (2-1-1)', 'description': 'Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively', 'interventionNames': ['Biological: Abbreviated Zagreb 2-1-1 schedule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Essen (1-1-1-1-1)', 'description': 'Rabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.', 'interventionNames': ['Biological: Standard Essen 1-1-1-1-1 schedule']}], 'interventions': [{'name': 'Abbreviated Zagreb 2-1-1 schedule', 'type': 'BIOLOGICAL', 'otherNames': ['PCEC Rabies vaccine for human use'], 'description': 'Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.', 'armGroupLabels': ['Zagreb (2-1-1)']}, {'name': 'Standard Essen 1-1-1-1-1 schedule', 'type': 'BIOLOGICAL', 'otherNames': ['PCEC Rabies vaccine for human use'], 'description': 'Subjects received the standard Essen regimen.', 'armGroupLabels': ['Essen (1-1-1-1-1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '053200', 'city': 'Jizhou', 'state': 'Hebei', 'country': 'China', 'geoPoint': {'lat': 37.55054, 'lon': 115.56871}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}