Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00260351
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2005-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Verorab™ in Indian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2005-11-29', 'studyFirstSubmitQcDate': '2005-11-29', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine', 'timeFrame': '6 months post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rabies;', 'rabies post-exposure;', 'category III'], 'conditions': ['Rabies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '* To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or,\n* To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.\n\nSecondary objectives:\n\n1. To describe the immunogenicity profile of each regimen\n2. To assess the safety of the vaccine in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with WHO category III rabies exposure\n* Subject aged at least 2 years old (day of second birthday)\n\nExclusion Criteria:\n\n* Subject unable to comply with the follow-up schedule of the protocol\n* Delayed post-exposure treatment (\\>72 hours between incident and treatment\n* Subject bitten by an observable animal at the inclusion visit\n* Subject with immune-compromised or underlying diseases which may lead to inferior immune response\n* Subject with known pregnancy at the time of inclusion\n* Subject enrolled or scheduled to be enrolled in another clinical study.\n* Subject with acute febrile illness/ axillary temperature \\> 37.5 degree celsius\n* Subject in whom blood sampling will be difficult.\n* Subject receiving chloroquine or other anti-malarial treatment\n* Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs\n* Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.)\n* Previous rabies immunization\n* Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin\n* Subject with clinical signs of rabies\n* Subject with known allergy to vaccine components (e.g. neomycin)\n* Subject who received blood and/or plasma transfusion within the past 3 months'}, 'identificationModule': {'nctId': 'NCT00260351', 'briefTitle': 'Immunogenicity and Safety of Verorab™ in Indian Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.', 'orgStudyIdInfo': {'id': 'RAB28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Participants on Thai Red Cross, TRC-ID regimen', 'interventionNames': ['Biological: Purified Verocell Rabies Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Participants on Zagreb-IM regimen', 'interventionNames': ['Biological: Purified Verocell Rabies Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Participants on Essen-IM regimen.', 'interventionNames': ['Biological: Purified Verocell Rabies Vaccine']}], 'interventions': [{'name': 'Purified Verocell Rabies Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PVRV, VERORAB'], 'description': '0.1 mL, ID (TRC regimen)', 'armGroupLabels': ['Group 1']}, {'name': 'Purified Verocell Rabies Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PVRV, VERORAB'], 'description': '0.5 mL, IM (ZAGREB regimen)', 'armGroupLabels': ['Group 2']}, {'name': 'Purified Verocell Rabies Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PVRV, VERORAB'], 'description': '0.5 mL, IM (ESSEN regimen)', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hyderabad', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Kolkata', 'country': 'India', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Lucknow', 'country': 'India', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}