Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT02146469
Status:
UNKNOWN
Last Update Posted:
2014-05-23
First Post:
2014-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}], 'ancestors': [{'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rate and GMCs after varicella vaccination', 'timeFrame': '35-42 days after each dose vaccination'}], 'secondaryOutcomes': [{'measure': 'The incidence of Adverse Events Following Immunization', 'timeFrame': '30 days after each dose vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['varicella vaccination'], 'conditions': ['Varicella']}, 'descriptionModule': {'briefSummary': 'The objective of the study is as follows:\n\n1. To know the antibody level during different interval after received 1 dose varicella vaccine.\n2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval.\n3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.\n\nTo achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.\n\nAll blood specimens will be tested by a third-party detection institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 1 to 7\n* Without a previous history of varicella\n* With an axillary temperature ≤37.5℃ at the time of vaccination\n* Appropriate varicella vaccination history\n* With guardian signing the informed consent and available for clinical observation\n\nExclusion Criteria:\n\n* Hypersensitive to any active substance of the vaccine including excipients and antibiotics\n* With acute illness, severe or acute attack of chronic illness or fever\n* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs\n* Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease\n* With a family or personal history of seizure, chronic illness, epilepsy or allergy\n* With unknown immunization history or unable to follow the immunization schedule of EPI\n* Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month\n* With hemorrhagic tendency or prolonged period of bleeding\n* Received whole blood, plasma or immunoglobulin within 5 months\n* Received systemic antibiotics or antiviral treatment for acute illness within 7 days\n* With an axillary temperature ≥38℃ within 3 days\n* Participating in another clinical trial\n* Any situation that might influence the consequence of the clinical trial'}, 'identificationModule': {'nctId': 'NCT02146469', 'briefTitle': 'Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Municipal Center for Disease Control and Prevention'}, 'officialTitle': 'Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine', 'orgStudyIdInfo': {'id': 'SH2012VAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'None varicella vaccine history', 'description': '2 doses with an 3 months interval', 'interventionNames': ['Biological: 2 doses with an 3 months interval']}, {'type': 'EXPERIMENTAL', 'label': '1 year after first dose', 'description': 'A second dose with an 1 year interval', 'interventionNames': ['Biological: A second dose with an 1 year interval']}, {'type': 'EXPERIMENTAL', 'label': '3 years after first dose', 'description': 'A second dose with an 3 year interval', 'interventionNames': ['Biological: A second dose with an 3 year interval']}, {'type': 'EXPERIMENTAL', 'label': '5 years after first dose', 'description': 'A second dose with an 5 year interval', 'interventionNames': ['Biological: A second dose with an 5 year interval']}, {'type': 'EXPERIMENTAL', 'label': 'Testing group for conbined immunization', 'description': '1 dose Varicella vaccine and 1 dose MMR given at the same time', 'interventionNames': ['Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group for conbined immunization', 'description': '1 dose MMR', 'interventionNames': ['Biological: 1 dose MMR']}], 'interventions': [{'name': '2 doses with an 3 months interval', 'type': 'BIOLOGICAL', 'description': 'varicella vaccination', 'armGroupLabels': ['None varicella vaccine history']}, {'name': 'A second dose with an 1 year interval', 'type': 'BIOLOGICAL', 'description': 'varicella vaccine', 'armGroupLabels': ['1 year after first dose']}, {'name': 'A second dose with an 3 year interval', 'type': 'BIOLOGICAL', 'description': 'varicella vaccine', 'armGroupLabels': ['3 years after first dose']}, {'name': 'A second dose with an 5 year interval', 'type': 'BIOLOGICAL', 'description': 'varicella vaccine', 'armGroupLabels': ['5 years after first dose']}, {'name': '1 dose Varicella vaccine and 1 dose MMR given at the same time', 'type': 'BIOLOGICAL', 'description': 'varicella vaccine and MMR', 'armGroupLabels': ['Testing group for conbined immunization']}, {'name': '1 dose MMR', 'type': 'BIOLOGICAL', 'description': 'MMR', 'armGroupLabels': ['Control group for conbined immunization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai municipal center for disease control and prevention', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaodong Sun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Municipal Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Municipal Center for Disease Control and Prevention', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Institute Of Biological Products', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}