Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-04-14 @ 9:58 PM
Study NCT ID:
NCT01812135
Status:
WITHDRAWN
Last Update Posted:
2021-07-29
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}], 'ancestors': [{'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Based on the previous study results, inactivated EV71 vaccine with aluminum adjuvant was elected to be used for the efficacy Phase III study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant', 'timeFrame': '2 months', 'description': 'Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \\>= 1:8'}], 'secondaryOutcomes': [{'measure': 'The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection, Viral, Enterovirus']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy males and females, aged from 6 to 11 months old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator\n2. Provided legal identification for the sake of recruitment.\n3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.\n4. Birth weight more than 2500 grams\n\nExclusion Criteria:\n\n1. History of Hand-foot-mouth Disease\n2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine\n3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain\n4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition\n5. Epilepsy, seizures or convulsions history, or family history of mental illness\n6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency\n7. History of asthma, angioedema, diabetes or malignancy\n8. History of thyroidectomy or thyroid disease that required medication within the past 12 months\n9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws\n10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen\n11. Acute illness or acute exacerbation of chronic disease within the past 7 days\n12. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)\n13. History of any blood products within 3 months\n14. Administration of any live attenuated vaccine within 28 days\n15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days\n16. Axillary temperature \\> 37.0 centigrade before vaccination\n17. Abnormal laboratory parameters before vaccination\n18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent"}, 'identificationModule': {'nctId': 'NCT01812135', 'briefTitle': 'Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants', 'orgStudyIdInfo': {'id': 'EV71-1001-II-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: 400U EV71 vaccine without adjuvant', 'description': '60 infants received 2 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant 28 days apart', 'interventionNames': ['Biological: 400 U EV71 vaccine with adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: 400U EV71 vaccine without adjuvant', 'description': '60 infants received 1 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant', 'interventionNames': ['Biological: 400 U EV71 vaccine with adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: 400U EV71 vaccine with adjuvant', 'description': '60 infants received 1 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant', 'interventionNames': ['Biological: 400 U EV71 vaccine with adjuvant']}], 'interventions': [{'name': '400 U EV71 vaccine with adjuvant', 'type': 'BIOLOGICAL', 'otherNames': ['EV71 vaccine'], 'description': '400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant', 'armGroupLabels': ['Group 1: 400U EV71 vaccine without adjuvant', 'Group 2: 400U EV71 vaccine without adjuvant', 'Group 3: 400U EV71 vaccine with adjuvant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'GuangXi Center for Diseases Control and Prevention', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'overallOfficials': [{'name': 'Yan-pin Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}