Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-01-22 @ 11:53 AM
Study NCT ID:
NCT02985320
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen', 'timeFrame': '90 days', 'description': 'Subjects whose pre-immune antibody level \\< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.'}, {'measure': 'The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen', 'timeFrame': '90 days', 'description': 'GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.'}, {'measure': 'The geometric mean fold increase (GMI) of each group after three-dose regimen', 'timeFrame': '90 days', 'description': 'The GMI is the increase of post-immune GMT from pre-immune GMT.'}], 'secondaryOutcomes': [{'measure': 'The incidences of solicited adverse events (AEs) of each group in both phase I and II trials', 'timeFrame': '7 days', 'description': 'Solicited AEs occurred within 7 days after each injection will be collected.'}, {'measure': 'The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials', 'timeFrame': '30 days', 'description': 'Unsolicited AEs occurred within 30 days after each injection will be collected.'}, {'measure': 'The incidences of serious adverse events (SAEs) of each group in both phase I and II trials', 'timeFrame': '30 days', 'description': 'SAEs occurred within 30 days after each injection will be collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sabin strain', 'Inactivated poliovirus vaccine', 'poliomyelitis', 'safety', 'immunogenicity', 'infant'], 'conditions': ['Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '30249424', 'type': 'DERIVED', 'citation': 'Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.', 'detailedDescription': 'This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;\n* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;\n* Proven legal identity;\n* Participants (≥ 18 years old), or guardians of the participants (\\< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;\n* Complying with the requirement of the study protocol;\n* Axillary temperature ≤ 37.0 °C;\n\nExclusion Criteria:\n\n* Breast feeding, pregnant, or expected to conceive in the next 60 days;\n* History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;\n* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;\n* Autoimmune disease or immunodeficiency/immunosuppressive;\n* serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;\n* severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;\n* History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;\n* Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;\n* Long term history of alcoholism or drug abuse;\n* Receipt of any of the following products:\n\n 1. Any subunit or inactivated vaccine within the past 7 day;\n 2. Any live attenuated vaccine within the past 14 days;\n 3. Any other investigational medicine(s) within the past 30 days;\n 4. Any blood product within the past 3 months;\n 5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;\n* Acute illness or acute exacerbation of chronic disease within the past 7 days;\n* Axillary temperature \\> 37.0 °C;\n* Infant participants with prior vaccination of poliovirus;\n* Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;'}, 'identificationModule': {'nctId': 'NCT02985320', 'briefTitle': 'Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants', 'orgStudyIdInfo': {'id': 'PRO-sIPV-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I Adult Group - High dosage', 'description': '* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;\n* Intervention: Single-dose regimen of high dosage investigational sIPV', 'interventionNames': ['Biological: Single-dose regimen of high dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Adult Group - Medium dosage', 'description': '* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;\n* Intervention: Single-dose regimen of medium dosage investigational sIPV', 'interventionNames': ['Biological: Single-dose regimen of medium dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Child Group - High dosage', 'description': '* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;\n* Intervention: Single-dose regimen of high dosage investigational sIPV', 'interventionNames': ['Biological: Single-dose regimen of high dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Child Group - Medium dosage', 'description': '* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;\n* Intervention: Single-dose regimen of medium dosage investigational sIPV', 'interventionNames': ['Biological: Single-dose regimen of medium dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Infant Group - High dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of high dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of high dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Infant Group - Medium dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of medium dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of medium dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Infant Group - Low dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of low dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of low dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'PhaseⅡExperimental Group - High dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of high dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of high dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'PhaseⅡExperimental Group - Medium dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of medium dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of medium dosage investigational sIPV']}, {'type': 'EXPERIMENTAL', 'label': 'PhaseⅡExperimental Group - Low dosage', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of low dosage investigational sIPV', 'interventionNames': ['Biological: Three-dose regimen of low dosage investigational sIPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PhaseⅡControl Group -commercialized sIPV', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention:Three-dose regimen of commercialized sIPV', 'interventionNames': ['Biological: Three-dose regimen of commercialized sIPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PhaseⅡ Control Group -commercialized IPV', 'description': '* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;\n* Intervention: Three-dose regimen of commercialized IPV', 'interventionNames': ['Biological: Three-dose regimen of commercialized IPV']}], 'interventions': [{'name': 'Single-dose regimen of high dosage investigational sIPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..', 'armGroupLabels': ['Phase I Adult Group - High dosage', 'Phase I Child Group - High dosage']}, {'name': 'Single-dose regimen of medium dosage investigational sIPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..', 'armGroupLabels': ['Phase I Adult Group - Medium dosage', 'Phase I Child Group - Medium dosage']}, {'name': 'Three-dose regimen of high dosage investigational sIPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..', 'armGroupLabels': ['Phase I Infant Group - High dosage', 'PhaseⅡExperimental Group - High dosage']}, {'name': 'Three-dose regimen of medium dosage investigational sIPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..', 'armGroupLabels': ['Phase I Infant Group - Medium dosage', 'PhaseⅡExperimental Group - Medium dosage']}, {'name': 'Three-dose regimen of low dosage investigational sIPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..', 'armGroupLabels': ['Phase I Infant Group - Low dosage', 'PhaseⅡExperimental Group - Low dosage']}, {'name': 'Three-dose regimen of commercialized sIPV', 'type': 'BIOLOGICAL', 'description': 'The control vaccine was manufactured by Chinese Academy of Medical Sciences.', 'armGroupLabels': ['PhaseⅡControl Group -commercialized sIPV']}, {'name': 'Three-dose regimen of commercialized IPV', 'type': 'BIOLOGICAL', 'description': 'The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).', 'armGroupLabels': ['PhaseⅡ Control Group -commercialized IPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221300', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Pizhou City Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'overallOfficials': [{'name': 'Yuemei Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}