Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00310635
Status:
COMPLETED
Last Update Posted:
2006-10-26
First Post:
2006-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C410218', 'term': 'serogroup C meningococcal conjugate vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2006-10-25', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.'}], 'secondaryOutcomes': [{'measure': 'Determination of antibody titers in naïve control subjects.'}, {'measure': 'Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.'}, {'measure': 'Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.'}]}, 'conditionsModule': {'keywords': ['Prevention of meningococcal infection'], 'conditions': ['Meningococcal Infection']}, 'descriptionModule': {'briefSummary': 'Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Months', 'minimumAge': '32 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children\n\nExclusion Criteria:\n\n* known hypersensitivity to any vaccine component\n* significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days\n* ascertained or suspected disease caused by N. meningitidis\n* household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days'}, 'identificationModule': {'nctId': 'NCT00310635', 'briefTitle': 'Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age', 'orgStudyIdInfo': {'id': 'M14P1E1'}, 'secondaryIdInfos': [{'id': 'Impact N° 1453'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Meningococcal C conjugate vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oppenheim', 'state': 'Kempten', 'country': 'Germany', 'facility': 'Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,', 'geoPoint': {'lat': 49.8547, 'lon': 8.35974}}], 'overallOfficials': [{'name': 'Vaccines - Information Services', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Vaccines & Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}]}}}