Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT02003495
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018074', 'term': 'Vaccines, Conjugate'}, {'id': 'C410218', 'term': 'serogroup C meningococcal conjugate vaccine'}], 'ancestors': [{'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-19', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination', 'timeFrame': '28 days after vaccination'}], 'secondaryOutcomes': [{'measure': 'to evaluate the adverse reactions after vaccination', 'timeFrame': 'Within 28 days after vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunogenicity, Safety, Meningococcal Conjugate Vaccine'], 'conditions': ['Meningitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.\n* Healthy permanent residence 2 months to 6 years old.\n* Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.\n* Axillary temperature ≤37.0 ℃.\n\nExclusion Criteria:\n\n* History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.\n* Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.\n* Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.\n* Receipt of blood or blood-derived products in the 3 months preceding vaccination\n* Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.\n* Receipt of any live virus vaccine in the 15 days preceding vaccination.\n* Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.\n* Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.\n* Thrombocytopenia.\n* History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.\n* Functional or anatomic asplenia.\n* History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.\n* Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).\n* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.\n* Any condition that, in the judgment of investigator, may affect trial assessment.'}, 'identificationModule': {'nctId': 'NCT02003495', 'briefTitle': 'Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Minhai Biotechnology Co., Ltd'}, 'officialTitle': 'Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China', 'orgStudyIdInfo': {'id': '2013L01041'}, 'secondaryIdInfos': [{'id': '2013L01041', 'type': 'REGISTRY', 'domain': 'China food and drug administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCV-ACYW135 Vaccine Group', 'description': 'Participants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine.\n\nParticipants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart.\n\nParticipants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart.\n\nParticipants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart.', 'interventionNames': ['Biological: MCV-ACYW135 Vaccine Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MPV-ACYW135 Vaccine Group', 'description': 'Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine', 'interventionNames': ['Biological: MPV-ACYW135 Vaccine Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MPV-A Vaccine Group', 'description': 'Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart.', 'interventionNames': ['Biological: MPV-A Vaccine Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MCV-AC Vaccine Group', 'description': 'Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart.', 'interventionNames': ['Biological: MCV-AC Vaccine Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hib Vaccine Group', 'description': 'Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart.', 'interventionNames': ['Biological: Hib Vaccine Group']}], 'interventions': [{'name': 'MCV-ACYW135 Vaccine Group', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal ( A, C, Y and W 135) conjugate vaccine'], 'description': '0.5ml, intramuscular', 'armGroupLabels': ['MCV-ACYW135 Vaccine Group']}, {'name': 'MPV-ACYW135 Vaccine Group', 'type': 'BIOLOGICAL', 'otherNames': ['Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine'], 'description': '0.5ml, intramuscular', 'armGroupLabels': ['MPV-ACYW135 Vaccine Group']}, {'name': 'MPV-A Vaccine Group', 'type': 'BIOLOGICAL', 'otherNames': ['Group A Meningococcal Polysaccharide vaccine'], 'description': '0.5ml, intramuscular', 'armGroupLabels': ['MPV-A Vaccine Group']}, {'name': 'MCV-AC Vaccine Group', 'type': 'BIOLOGICAL', 'otherNames': ['Group A and C Meningococcal conjugate vaccine'], 'description': '0.5ml, intramuscular', 'armGroupLabels': ['MCV-AC Vaccine Group']}, {'name': 'Hib Vaccine Group', 'type': 'BIOLOGICAL', 'otherNames': ['Haemophilus Influenzae Type b Conjugate Vaccine'], 'description': '0.5ml, intramuscular', 'armGroupLabels': ['Hib Vaccine Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'shengli xia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Provincial Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Minhai Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}