Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-27 @ 5:42 AM
Study NCT ID:
NCT02001233
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006232', 'term': 'Hand, Foot and Mouth Disease'}], 'ancestors': [{'id': 'D003384', 'term': 'Coxsackievirus Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after the first vaccination.\n\nThroat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease for the detection of PCR assays and the isolation of EV71.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10077}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination', 'timeFrame': 'Within the second year after the second vaccination', 'description': 'to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71'}], 'secondaryOutcomes': [{'measure': 'The GMT of anti-EV71 antibodies in serum two years after second vaccination', 'timeFrame': '26 months after second vaccination', 'description': 'to evaluate the immune persistence of anti-EV71 antibodies in serum'}, {'measure': 'Frequency of serious adverse events (SAEs) with the second year after the second vaccination', 'timeFrame': 'within the second year after the second vaccination', 'description': 'Frequency of serious adverse events in healthy infants during the oney-year follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EV71 vaccine', 'EV71-associated HFMD', 'efficacy', 'safety', 'immune persistence'], 'conditions': ['Hand, Foot and Mouth Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.', 'detailedDescription': 'The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.\n\nThis study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Chinese infants aged 6 to 35 months old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.\n\nExclusion Criteria:\n\n* subjects who refuse to continue in the study.'}, 'identificationModule': {'nctId': 'NCT02001233', 'briefTitle': 'A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine', 'orgStudyIdInfo': {'id': 'PRO-EV71-3003-0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EV71 Vaccine', 'description': 'Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28', 'interventionNames': ['Biological: EV71 vaccine']}, {'label': 'Placebo', 'description': 'placebo in 5000 infants aged 6-35 months old on day0,28'}], 'interventions': [{'name': 'EV71 vaccine', 'type': 'BIOLOGICAL', 'description': 'inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval', 'armGroupLabels': ['EV71 Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '222100', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Ganyu', 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '225400', 'city': 'Taizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Taixing', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'zip': '224300', 'city': 'Yancheng', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Sheyang', 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}], 'overallOfficials': [{'name': 'Feng-Cai Zhu, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Center for Diseases Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}