Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 2:24 PM
Study NCT ID:
NCT01278433
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2011-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.', 'timeFrame': 'Up to 30 days after each vaccination', 'description': 'A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polio', 'Poliovirus', 'IMOVAX Polio™'], 'conditions': ['Polio', 'Poliomyelitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.\n\nObjective:\n\nTo describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.', 'detailedDescription': 'Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '60 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.\n* Subject's parent /legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio according to the schedule. one injection at 2, 3, 4 months old respectively;\n* Informed consent form obtained by the subject's parent/legal representative.\n* Subject plan to live in the selected study sites for at least three months after inclusion.\n\nExclusion Criteria:\n\n* Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)\n* Acute medical illness with or without fever within the last 72 hours.\n* Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)\n* Participation in another clinical trial at the same time.\n* Contraindications to vaccination according to IMOVAX Polio™ leaflet.\n* Subject plan to leave the study sites for at least three months after inclusion."}, 'identificationModule': {'nctId': 'NCT01278433', 'briefTitle': 'A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study', 'orgStudyIdInfo': {'id': 'IPV34'}, 'secondaryIdInfos': [{'id': 'UTN: U1111 1115 6566', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Participants receiving their first dose of polio vaccine', 'interventionNames': ['Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine']}], 'interventions': [{'name': 'IMOVAX Polio™: Inactivated Poliomyelitis Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['IMOVAX Polio™'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'country': 'China', 'geoPoint': {'lat': 26.36828, 'lon': 115.34289}}, {'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 45.88029, 'lon': 127.13373}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinan', 'country': 'China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'country': 'China', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Qingdao', 'country': 'China', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shenyang', 'country': 'China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'country': 'China', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuhan', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'country': 'China', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Zheng Zho', 'country': 'China'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}