Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT01365494
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2011-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
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': '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': 'All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule.', 'otherNumAtRisk': 126, 'otherNumAffected': 3, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.', 'otherNumAtRisk': 123, 'otherNumAffected': 8, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule.'}, {'id': 'OG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.076', 'upperLimit': '0.11'}, {'value': '0.099', 'groupId': 'OG001', 'lowerLimit': '0.083', 'upperLimit': '0.12'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '13'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs-Zagreb and Essen at day 14', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.19', 'groupDescription': 'To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 0 and Day 14', '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 on study day 14 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': 'Per Protocol Set-All subjects in the FAS (Full analysis set) population who:correctly receive the vaccine, provide evaluable serum sample at day 14, and have no major protocol violation as defined prior to analysis'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule.'}, {'id': 'OG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '15'}]}]}, {'title': 'Day 7(N=125,123)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Day 14(N=124,123)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Day 42(N=124,121)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study day 7, 14 and 42', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.', 'unitOfMeasure': 'Percentages of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized'}, {'type': 'SECONDARY', 'title': 'Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule.'}, {'id': 'OG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.091', 'groupId': 'OG000', 'lowerLimit': '0.077', 'upperLimit': '0.11'}, {'value': '0.099', 'groupId': 'OG001', 'lowerLimit': '0.084', 'upperLimit': '0.12'}]}]}, {'title': 'Day 7(N=125,123)', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.78'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '2.07'}]}]}, {'title': 'Day 14(N=124,123)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '13'}]}]}, {'title': 'Day 42(N=124,121)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '16'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '17'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs-Zagreb and Essen at day 7', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.48', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs-Zagreb and Essen at day 42', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.07', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 7, Day 14 and Day 42', 'description': 'Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules', 'unitOfMeasure': 'IU\\ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects Reporting Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule.'}, {'id': 'OG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Medically Attended AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawal from study due to AE', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period', 'description': 'Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.', 'unitOfMeasure': 'percentages of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population- All subjects in the Exposed population who provide post vaccination safety data and as vaccinated (as treated)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule.'}, {'id': 'FG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zagreb', 'description': 'Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules.'}, {'id': 'BG001', 'title': 'Essen', 'description': 'Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)\n\nPurified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2011-05-30', 'resultsFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14', 'timeFrame': 'On Day 0 and Day 14', '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 on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42', 'timeFrame': 'Study day 7, 14 and 42', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.'}, {'measure': 'Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations', 'timeFrame': 'Day 0, Day 7, Day 14 and Day 42', 'description': 'Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules'}, {'measure': 'Percentages of Subjects Reporting Adverse Events (AEs)', 'timeFrame': 'All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period', 'description': 'Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.'}]}, 'conditionsModule': {'keywords': ['Rabies', 'rabies vaccines', 'post-exposure prophylaxis'], 'conditions': ['Rabies']}, 'referencesModule': {'references': [{'pmid': '25692792', 'type': 'DERIVED', 'citation': 'Mahendra BJ, Narayana DA, Agarkhedkar S, Ravish HS, Harish BR, Agarkhedkar S, Madhusudana SN, Belludi A, Ahmed K, Jonnalagedda R, Vakil H, Bhusal C, Arora AK. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34. doi: 10.4161/21645515.2014.995059.'}]}, 'descriptionModule': {'briefSummary': 'This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females of age ≥ 18 years.\n2. Individuals who had given written consent.\n3. Individuals in good health and available for all the visits scheduled in the study.\n\nExclusion Criteria:\n\n1. Pregnancy or unwillingness to practice acceptable contraception.\n2. A history of Rabies vaccination.\n3. History of allergy to egg protein.\n4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.\n5. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.\n6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.\n7. Treatment with an anti-malarial drug, up to two months prior to the study.\n8. Individuals who received any other vaccines within 28 days prior to enrollment.\n9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.\n10. Any planned surgery during the study period.\n11. Subjects who have cancer disorders excluding nonmelanotic skin cancer."}, 'identificationModule': {'nctId': 'NCT01365494', 'briefTitle': 'Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects', 'orgStudyIdInfo': {'id': 'V49_25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A-Zagreb', 'description': 'Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)', 'interventionNames': ['Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B-Essen', 'description': 'Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)', 'interventionNames': ['Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine']}], 'interventions': [{'name': 'Purified Chick Embryo Cell Inactivated Rabies Vaccine', 'type': 'BIOLOGICAL', 'description': 'Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.', 'armGroupLabels': ['Group A-Zagreb', 'Group B-Essen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560070', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Kempegowda Institute of Medical Sciences Hospital (KIMS)', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '571401', 'city': 'Mandya', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mandya Institute of Medical Sciences', 'geoPoint': {'lat': 12.5223, 'lon': 76.89746}}, {'zip': '411018', 'city': 'Pune', 'state': 'MS', 'country': 'India', 'facility': 'Padmashree Dr. D.Y Patil Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}