Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT01273233
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2011-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infection; Viral, Enterovirus']}, 'referencesModule': {'references': [{'pmid': '22426327', 'type': 'DERIVED', 'citation': 'Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults', 'detailedDescription': 'A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy males and females, aged from 18 to 49 years 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 are able to understand and sign informed consents.\n\nExclusion Criteria:\n\n1. Histroy of Hand-foot-mouth Disease\n2. Women of lactation, pregnancy or about to be pregnant in 60 days\n3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine\n4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain\n5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition\n6. Epilepsy, seizures or convulsions history, or family history of mental illness\n7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency\n8. History of asthma, angioedema, diabetes or malignancy\n9. History of thyroidectomy or thyroid disease that required medication within the past 12 months\n10. 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\n11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen\n12. Acute illness or acute exacerbation of chronic disease within the past 7 days\n13. 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)\n14. History of any blood products within 3 months\n15. Administration of any live attenuated vaccine within 28 days\n16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days\n17. Axillary temperature \\> 37.0 centigrade before vaccination\n18. Abnormal laboratory parameters before vaccination\n19. 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': 'NCT01273233', 'briefTitle': 'Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Blinded, Randomized and Controlled Clinical Trial of An Inactivated Enterovirus Type 71 Vaccine in Healthy Adults', 'orgStudyIdInfo': {'id': 'EV71-1001-Ia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: 200U EV71 vaccine', 'description': '12 adults received 3 doses of 200U EV71 vaccine 14 days apart', 'interventionNames': ['Biological: Inactivated Enterovirus Type 71 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: 400U EV71 vaccine', 'description': '12 adults received 3 doses of 400U EV71 vaccine 14 days apart', 'interventionNames': ['Biological: Inactivated Enterovirus Type 71 Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1: Placebo', 'description': '6 adults received 3 doses of placebo 14 days apart', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Placebo', 'description': '6 adults received 3 doses of placebo 14 days apart', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Inactivated Enterovirus Type 71 Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['EV71 Vaccine'], 'description': 'A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)', 'armGroupLabels': ['Group 1: 200U EV71 vaccine', 'Group 2: 400U EV71 vaccine']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['EV71 Vaccine'], 'description': 'Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.', 'armGroupLabels': ['Group 1: Placebo', 'Group 2: Placebo']}]}, '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-ping 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'}}}}