Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT04236960
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2018-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], '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'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events after each vaccination', 'timeFrame': '30 days after vaccination', 'description': 'Percentage of subjects with local and systemic adverse events after each dose of vaccination'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious adverse events after vaccination', 'timeFrame': 'day 0 to 6 months after last dose', 'description': 'Percentage of subjects with serious adverse events from day 0 to 6 months after last dose'}, {'measure': 'Blood routine in 2 years and above subjects', 'timeFrame': '3 days after vaccination', 'description': 'content of hemoglobin（g/dL）、white blood cell count（WBC）、blood platelet count（PLT）3 days after vaccination in 2 years and above subjects'}, {'measure': 'Liver function in 2 years and above subjects', 'timeFrame': '3 days after vaccination', 'description': 'Alanine aminotransferase（ALT），Aspartate aminotransferase（AST），Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects'}, {'measure': 'Renal function in 2 years and above subjects', 'timeFrame': '3 days after vaccination', 'description': 'Creatinine（CR），Urea nitrogen（BUN）3 days after vaccination in 2 years and above subjects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningitis, Meningococcal, Serogroup A', 'Meningitis, Meningococcal, Serogroup C', 'Meningitis, Meningococcal, Serogroup Y', 'Meningitis, Meningococcal, Serogroup W135'], 'conditions': ['Meningococcal Infections']}, 'descriptionModule': {'briefSummary': 'A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy children, adolescents and adults (age range: 2 months to 55 years old) based on medical history, physical examination or judgement of the investigator\n* Subjects aged ≥18 years old voluntarily agree to participate in this clinical study and sign the informed consent form; or for subjects aged \\<18 years old, the legal guardian voluntarily agrees that his/her child to participate in this clinical study, and sign the informed consent form. For juveniles aged ≥8 years old, both the subject and his/her legal guardians should voluntarily agree to participate in this clinical study and sign the informed consent form.\n* The subject and his/her legal guardians as well as the family members are able to follow the request of clinical study protocol.\n* Subjects aged 2 or 3 months should have no vaccination history of any meningococcal vaccine; subjects aged 7\\~23 months should have not received any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in National Immunization Program, and the time since last vaccination of meningococcal group A polysaccharide vaccine should be \\>6 months; for subjects ≥2 years, the time since last vaccination of meningococcal vaccine should be \\>2 years.\n* For subjects aged ≥2 years, there should be no clinically significant abnormal hematology, liver and renal function results judged by the investigator before immunization.\n* Subjects should not receive any attenuated live vaccine 14 days, or inactivated vaccine 7 days before or after vaccination.\n* Axillary temperature ≤37.0℃.\n\nExclusion Criteria for First Dose:\n\n* Subjects aged 2 or 3 months at enrollment with birth weight \\<2.5 kg.\n* Subjects aged 2 or 3 months at enrollment had received blood products and immunoglobin after birth; subjects of other age groups had received blood products or immunoglobin in \\<3 months before vaccination.\n* Subjects aged \\<12 months at enrollment are diagnosed as with pathological jaundice or have a history of pathological jaundice.\n* Subjects aged \\<2 months at enrollment had abnormal labor (dystocia, assisted instrumental delivery) or with the history of asphyxia or nervous damage.\n* Subjects aged ≥18 years who are planning pregnancy, or are pregnant, or are breastfeeding.\n* Subjects aged ≥18 years with uncontrollable hypertension (during screening: systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg).\n* Subjects are known to be allergic to certain components contained in the investigational vaccine (mainly include: capsular polysaccharide of meningococcal group A, group C, group Y, or group W135, diphtheria toxoid or diphtheria antigen).\n* Subjects with the history of serious allergy to any vaccine or drug. (including but not limited to: allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction \\[Arthus reaction\\]).\n* Subjects with the history of meningitis.\n* Subjects with moderate to severe fever (axillary temperature ≥38.0℃) in last 3 days.\n* Subjects with the history or family history of convulsion, seizure, encephalopathy, or psychiatric disorders.\n* Subjects with definite diagnosis of thrombocytopenia or other coagulation disorders.\n* Subjects with primary or secondary immunological dysfunction, including HIV infection, disorder or resection of thyroid, pancreas, liver, spleen or kidney; or needed treatment due to thyroid disorders in last 12 months (time interval \\<12 months).\n* Subjects have received immunosuppressive therapy, cytotoxic therapy, corticosteroid hormone (not include corticosteroid hormone spray for allergic rhinitis, epithelial corticosteroid hormone for acute and non-complicated dermatitis) in last 6 months (time interval \\<6 months).\n* Subjects with known congenital malformation, developmental disabilities or clinically confirmed serious chronic diseases (e.g., Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome, etc.).\n* Subjects with known or suspected diseases that are likely to affect the vaccination by investigators' judgement, such as: serious respiratory diseases, acute infection or the active period of chronic disease, serious cardiovascular diseases, liver and renal diseases, malignant tumors, serious infectious or allergic skin diseases.\n* Subjects are participating or plan to participate in other clinical trials of investigational medications.\n* Any other conditions that may influence the evaluation of clinical study by investigators' judgement.\n\nExclusion Criteria for Second and Third Dose:\n\n* New conditions that conforms with the exclusion criteria for first dose.\n* Subjects that develop grade 4 adverse reactions after vaccination of investigational vaccine.\n* Subjects that develop serious allergic reactions after vaccination of investigational vaccine.\n* Any other conditions that may influence the evaluation of clinical study by investigators' judgement based on the exclusion criteria for first dose."}, 'identificationModule': {'nctId': 'NCT04236960', 'briefTitle': 'Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Walvax Biotechnology Co., Ltd.'}, 'officialTitle': 'Phase I Clinical Study of Meningococcal Group ACYW135 Conjugate Vaccine', 'orgStudyIdInfo': {'id': '008152017002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18~55 yrs', 'description': '1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.', 'interventionNames': ['Biological: Meningococcal Group ACYW135 Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2~17 yrs', 'description': '1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.', 'interventionNames': ['Biological: Meningococcal Group ACYW135 Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '7~23 mos', 'description': '2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose.', 'interventionNames': ['Biological: Meningococcal Group ACYW135 Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '3 mos', 'description': '3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses.', 'interventionNames': ['Biological: Meningococcal Group ACYW135 Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2 mos', 'description': '3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses.', 'interventionNames': ['Biological: Meningococcal Group ACYW135 Conjugate Vaccine']}], 'interventions': [{'name': 'Meningococcal Group ACYW135 Conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose in Stage 1 (2\\~55 yrs), 2 doses in Stage 2 (7\\~23 mos), and 3 doses in Stage 3 (2\\&3 mos)', 'armGroupLabels': ['18~55 yrs', '2 mos', '2~17 yrs', '3 mos', '7~23 mos']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walvax Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}