Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT02919293
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061963', 'term': 'HibTITER protein, Haemophilus influenzae'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine', 'timeFrame': 'Day 30 post-vaccination'}, {'measure': 'Occurrence of adverse events during a 30 day follow-up period after each vaccination', 'timeFrame': '30 day after each vaccination'}], 'secondaryOutcomes': [{'measure': 'Occurrence of severe adverse events within six months post-vaccination', 'timeFrame': 'six months post-vaccination'}, {'measure': 'Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine', 'timeFrame': 'Day 30 post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.\n\nPrimary objective:\n\n* To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.\n* To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.\n\nSecondary objective:\n\n•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Health infants aged 2 to 5 months.\n* Legal guardian has signed written informed consent.\n* Guardian may finish the whole visit in the judgment of investigator.\n* 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.\n* Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.\n\nExclusion Criteria:\n\n* Fever, body temperature ≥37.1℃.\n* History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.\n* Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.\n* Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.\n* Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.\n* Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.\n* Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.\n* Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial."}, 'identificationModule': {'nctId': 'NCT02919293', 'briefTitle': 'Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd'}, 'officialTitle': 'Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age', 'orgStudyIdInfo': {'id': '085201602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant-Free MenAC-Hib Conjugate Vaccine Group', 'description': 'Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.', 'interventionNames': ['Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant MenAC-Hib Conjugate Vaccine Group', 'description': 'Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.', 'interventionNames': ['Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)']}], 'interventions': [{'name': 'Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)', 'type': 'BIOLOGICAL', 'otherNames': ['HibACon', 'MenAC-Hib'], 'description': '30μg /dose, Intramuscular', 'armGroupLabels': ['Adjuvant-Free MenAC-Hib Conjugate Vaccine Group']}, {'name': 'Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['HibACon', 'MenAC-Hib'], 'description': '0.5ml /dose, Intramuscular', 'armGroupLabels': ['Adjuvant MenAC-Hib Conjugate Vaccine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '525200', 'city': 'Gaozhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zeng peiyu, Bachelor', 'role': 'CONTACT', 'email': 'gzcdc6578613@163.com', 'phone': '86-668-6578613'}], 'facility': 'Gaozhou Center for Disease Control and Prevention', 'geoPoint': {'lat': 21.91965, 'lon': 110.85678}}], 'centralContacts': [{'name': 'Zeng peiyu, Bachelor', 'role': 'CONTACT', 'email': 'gzcdc6578613@163.com', 'phone': '86-668-6578613'}], 'overallOfficials': [{'name': 'Du lin, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Guangdong Center for Disease Prevention and Control', 'class': 'OTHER_GOV'}, {'name': 'Guizhou Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'National Institutes for Food and Drug Control, China', 'class': 'OTHER'}, {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Simoon Record Pharma Information Consulting Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}