Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02481232
Status:
UNKNOWN
Last Update Posted:
2015-06-25
First Post:
2015-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], 'ancestors': [{'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': 'D008589', 'term': 'Meningococcal 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'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-23', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systemic and local reactions 30 days after full-course vaccination', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Meningococcal Meningitis']}, 'descriptionModule': {'briefSummary': 'Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old', 'detailedDescription': 'There are five different age groups(18\\~55 years/7\\~17 years/1\\~6 years/7\\~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7\\~10 months\\&2 months age groups,there are 2\\&3 injection seperately. Each injection interval is 1 months.\n\nAfter 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7\\~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.\n\nData collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants unimmunized Group A\\&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2\\~11 months-old, and healthy toddler more than 1-year-old without booster immunization.\n* The guardian or himself informed consent, and signed the informed consent form;\n* The guardian and family agreed to abide by the requirements of clinical trial scheme;\n* Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;\n* the axillary temperature \\< 37.1 ℃;\n* 2-months-old group in the age of 61-90 days;\n* 7-months-old group in the age of 211-300 days;\n* 1-year-old group in age of one full year of life.\n\nExclusion Criteria:\n\n* Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;\n* Neomycin, streptomycin and polymyxin B allergies;\n* With immunodeficiency, immunosuppressant therapy;\n* History of meningitis;\n* Women in lactation or pregnant;\n* Acute febrile diseases and infectious diseases;\n* History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;\n* Had a severe allergic reaction of vaccination in the past;\n* Took oral steroids more than 14 days in last month;\n* Had high fever (axillary temperature≥38.0℃ or higher)in the past three days;\n* Prepare to attend or is in any other drug clinical study;\n* Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.'}, 'identificationModule': {'nctId': 'NCT02481232', 'briefTitle': 'A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lanzhou Institute of Biological Products Co., Ltd'}, 'officialTitle': 'A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine', 'orgStudyIdInfo': {'id': 'MCV4-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'freeze-dried group ACYW135 MCV 4μg', 'description': '4μg group: vaccines serial number is A0001-A0100（18-55 years-old group A0001-A0020，7-17 years-old group A0021-A0040，1-6 years-old group A0041-A0060，7-10 months-old group A0061-A0080，2 months-old group A0081-A0100）', 'interventionNames': ['Biological: freeze-dried group ACYW135 MCV']}, {'type': 'EXPERIMENTAL', 'label': 'freeze-dried group ACYW135 MCV 8μg', 'description': '8μg group: vaccines serial number is B0001-B0100（18-55 years-old group B0001-B0020，7-17 years-old group B0021-B0040，1-6 years-old group B0041-B0060，7-10 months-old group B0061-B0080，2 months-old group B0081-B0100）', 'interventionNames': ['Biological: freeze-dried group ACYW135 MCV']}], 'interventions': [{'name': 'freeze-dried group ACYW135 MCV', 'type': 'BIOLOGICAL', 'description': 'Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population', 'armGroupLabels': ['freeze-dried group ACYW135 MCV 4μg', 'freeze-dried group ACYW135 MCV 8μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faxian Zhan, Manager', 'role': 'CONTACT', 'email': 'zhanfx@163.com', 'phone': '008613908639947'}], 'facility': 'Hubei CDC', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zhiqiang Zhao, Manager', 'role': 'CONTACT', 'email': 'matinzhao@sina.com', 'phone': '008613919133537'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lanzhou Institute of Biological Products Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}