Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT01680016
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2012-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039481', 'term': 'hemoglobin A2 Zagreb'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Whole study period (From day 1 to day 43)', 'description': 'Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Zagreb(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22', 'otherNumAtRisk': 121, 'otherNumAffected': 64, 'seriousNumAtRisk': 121, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29', 'otherNumAtRisk': 119, 'otherNumAffected': 63, 'seriousNumAtRisk': 119, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22', 'otherNumAtRisk': 200, 'otherNumAffected': 19, 'seriousNumAtRisk': 200, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29', 'otherNumAtRisk': 200, 'otherNumAffected': 24, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}], 'seriousEvents': [{'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0v'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.052', 'groupId': 'OG000', 'lowerLimit': '0.048', 'upperLimit': '0.056'}, {'value': '0.054', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.058'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '16'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs between two groups(Day 15)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.02', 'groupDescription': 'To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15)', 'description': 'Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.'}, {'type': 'PRIMARY', 'title': 'Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.057', 'groupId': 'OG000', 'lowerLimit': '0.052', 'upperLimit': '0.063'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.055', 'upperLimit': '0.066'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000', 'lowerLimit': '7.34', 'upperLimit': '10'}, {'value': '7.89', 'groupId': 'OG001', 'lowerLimit': '6.75', 'upperLimit': '9.21'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs between two groups(Day 15)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.35', 'groupDescription': 'To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb( ≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(58,56,56,54,114,110)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.045', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day 15(58,56,56,54,114, 110)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '97', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '190', 'groupId': 'OG004'}, {'value': '188', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥61 Years)', 'description': '≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥61 Years)', 'description': '≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(93,93,97,95,190,188)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.026', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '8'}]}]}, {'title': 'Day 15 (93,93,97,95,190, 188)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG003', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG004', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG005', 'lowerLimit': '97', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '113', 'groupId': 'OG004'}, {'value': '111', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb( ≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(57,56,56,55,113,111)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.045', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day 43 (57,56,56,55,113,111)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '97', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '188', 'groupId': 'OG004'}, {'value': '183', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥61 Years)', 'description': '≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥61 Years)', 'description': '≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(92,90,96,93,188,183)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.026', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '8'}]}]}, {'title': 'Day 43 (92,90,96,93,188,183)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '98', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.'}, {'type': 'PRIMARY', 'title': 'Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '121', 'groupId': 'OG004'}, {'value': '119', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb( ≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Injection Site Erythema(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Injection Site Induration(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Injection Site Pain(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}]}, {'title': 'Nausea(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}, {'title': 'Arthralgia(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Headache(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Loss of Appetite(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Body Temp. (≥38°C)(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Low Grade Fever(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Medium Grade Fever(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'High Grade Fever(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Analge,Antipyr Used(N=59,58,60,60,119,118)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 7 postvaccination', 'description': 'Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.'}, {'type': 'PRIMARY', 'title': 'Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '200', 'groupId': 'OG004'}, {'value': '200', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥61 Years)', 'description': '≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥61 Years)', 'description': '≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Injection Site Erythema(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Injection Site Induration(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Injection Site Pain(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Nausea(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Arthralgia(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Headache(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Loss of Appetite(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Body Temp.(≥38°C)(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Low Grade Fever(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Medium Grade Fever(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'High Grade Fever(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Analgesic,Antipyretic use(N=98,100,99,100,197,200)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 7 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set'}, {'type': 'SECONDARY', 'title': 'GMCs of RVNA Titer 42 Days After First Vaccination in Children.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '113', 'groupId': 'OG004'}, {'value': '111', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤11 Years)', 'description': '≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥12 to ≤17 Years)', 'description': '≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb( ≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(N=57,56,56,55,113,111)', 'categories': [{'measurements': [{'value': '0.054', 'groupId': 'OG000', 'lowerLimit': '0.048', 'upperLimit': '0.06'}, {'value': '0.053', 'groupId': 'OG001', 'lowerLimit': '0.048', 'upperLimit': '0.059'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.046', 'upperLimit': '0.055'}, {'value': '0.055', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '0.06'}, {'value': '0.052', 'groupId': 'OG004', 'lowerLimit': '0.048', 'upperLimit': '0.056'}, {'value': '0.054', 'groupId': 'OG005', 'lowerLimit': '0.05', 'upperLimit': '0.058'}]}]}, {'title': 'Day 43(N=57,56,56,55,113,111)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '29'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '16'}, {'value': '23', 'groupId': 'OG003', 'lowerLimit': '19', 'upperLimit': '28'}, {'value': '13', 'groupId': 'OG004', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '24', 'groupId': 'OG005', 'lowerLimit': '21', 'upperLimit': '27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43)', 'description': 'Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Concentration (IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '188', 'groupId': 'OG004'}, {'value': '183', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 to ≤60 Years)', 'description': '≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG002', 'title': 'Zagreb(≥61 Years)', 'description': '≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG003', 'title': 'Essen(≥61 Years)', 'description': '≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'OG004', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22'}, {'id': 'OG005', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Day 1(92,90,96,93,188,183)', 'categories': [{'measurements': [{'value': '0.063', 'groupId': 'OG000', 'lowerLimit': '0.054', 'upperLimit': '0.074'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.052', 'upperLimit': '0.07'}, {'value': '0.052', 'groupId': 'OG002', 'lowerLimit': '0.047', 'upperLimit': '0.058'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0.054', 'upperLimit': '0.068'}, {'value': '0.057', 'groupId': 'OG004', 'lowerLimit': '0.052', 'upperLimit': '0.063'}, {'value': '0.06', 'groupId': 'OG005', 'lowerLimit': '0.055', 'upperLimit': '0.066'}]}]}, {'title': 'Day 43(92,90,96,93,188,183)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9.36', 'upperLimit': '15'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '20'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '9.39', 'upperLimit': '15'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '8.67', 'upperLimit': '14'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG005', 'lowerLimit': '11', 'upperLimit': '16'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43)', 'description': 'Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Concentration (IU/ml)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.'}, {'type': 'PRIMARY', 'title': 'Number of Children Who Reported Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Any unsolicited AEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related unsolicited AEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Premature withdrawals due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From V1/day 1 (postvaccination) through V7/study termination day 43', 'description': 'The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \\[SAE\\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.'}, {'type': 'PRIMARY', 'title': 'Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'OG001', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'classes': [{'title': 'Any unsolicited AEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related unsolicited AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Premature withdrawals due to AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from V1/day 1 (postvaccination) through V7/study termination day 43', 'description': 'The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \\[SAE\\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zagreb(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22'}, {'id': 'FG001', 'title': 'Essen(≥6 to ≤17 Years)', 'description': '≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'FG002', 'title': 'Zagreb(≥51 Years)', 'description': '≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'FG003', 'title': 'Essen(≥51 Years)', 'description': '≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '196'}, {'groupId': 'FG003', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'The Subject went out of The Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at Mengshan CDC', 'preAssignmentDetails': 'All enrolled subjects were included in the trial'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zagreb', 'description': 'Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22'}, {'id': 'BG001', 'title': 'Essen', 'description': 'Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Children (≥6 to ≤17 Years)', 'categories': [{'measurements': [{'value': '11', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '10.8', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '10.9', 'spread': '3.0', 'groupId': 'BG002'}]}]}, {'title': 'Older Adults (≥51 Years)', 'categories': [{'measurements': [{'value': '62.1', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female (≥6 to ≤17 Years)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Male (≥6 to ≤17 Years)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Female (≥51 Years)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}, {'title': 'Male (≥51 Years)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}], 'populationDescription': 'Enrolled set:All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 644}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2012-09-03', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2012-09-03', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-22', 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15)', 'description': 'Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur', 'timeFrame': 'Days 1 to 7 postvaccination', 'description': 'Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur', 'timeFrame': 'Days 1 to 7 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Number of Children Who Reported Unsolicited Adverse Events (AEs)', 'timeFrame': 'From V1/day 1 (postvaccination) through V7/study termination day 43', 'description': 'The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \\[SAE\\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.'}, {'measure': 'Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)', 'timeFrame': 'from V1/day 1 (postvaccination) through V7/study termination day 43', 'description': 'The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \\[SAE\\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur', 'timeFrame': 'Before vaccination (day 1) and 14 days after first vaccination (day 15).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43).', 'description': 'Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'GMCs of RVNA Titer 42 Days After First Vaccination in Children.', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43)', 'description': 'Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.', 'timeFrame': 'Before vaccination (day 1) and 42 days after first vaccination (day 43)', 'description': 'Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rabies virus, postexposure, vaccine schedule, children, older adults'], 'conditions': ['Rabies']}, 'referencesModule': {'references': [{'pmid': '25692350', 'type': 'DERIVED', 'citation': 'Li R, Li Y, Wen S, Wen H, Nong Y, Mo Z, Xie F, Pellegrini M. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study. Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.', 'detailedDescription': 'This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1.\n\n240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio.\n\nThe primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals between 6-17 years of age and 51 years of age or older\n* Individuals who were in good health\n* Provided consent, complied with study procedures and duration of follow-up\n\nExclusion Criteria:\n\n* Contraindications to vaccination with rabies vaccine\n* Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination\n* Known hypersensitivity to the components of the vaccine\n* Previously received any rabies vaccine or immune globulin\n* Previous or planned treatment with antimalarial medications\n* History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy\n* Female subjects who were pregnant or unwilling to practice acceptable birth control methods\n* Individuals enrolled or plans to enroll in another investigational trial'}, 'identificationModule': {'nctId': 'NCT01680016', 'briefTitle': 'A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults', 'orgStudyIdInfo': {'id': 'V49_24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zagreb(≥6 to ≤17 Years)', 'interventionNames': ['Biological: Zagreb']}, {'type': 'EXPERIMENTAL', 'label': 'Zagreb(≥51 Years)', 'interventionNames': ['Biological: Zagreb']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Essen(≥6 to ≤17 Years)', 'interventionNames': ['Biological: Essen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Essen(≥51 Years)', 'interventionNames': ['Biological: Essen']}], 'interventions': [{'name': 'Zagreb', 'type': 'BIOLOGICAL', 'description': 'Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22', 'armGroupLabels': ['Zagreb(≥51 Years)', 'Zagreb(≥6 to ≤17 Years)']}, {'name': 'Essen', 'type': 'BIOLOGICAL', 'description': 'Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29', 'armGroupLabels': ['Essen(≥51 Years)', 'Essen(≥6 to ≤17 Years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530028', 'city': 'Mengshan', 'state': 'Guangxi', 'country': 'China', 'facility': 'Mengshan Center for Disease Prevention and Control (CDC)', 'geoPoint': {'lat': 24.19558, 'lon': 110.5209}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}