Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02785705
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023321', 'term': 'Poliovirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of infants with seroconversion in susceptible population', 'timeFrame': '30 days after vaccination', 'description': 'Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight.'}, {'measure': 'Proportion of infants with seroconversion in unsusceptible population', 'timeFrame': '30 days after vaccination', 'description': 'Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants.'}], 'primaryOutcomes': [{'measure': 'Proportion of infants with seroconversion', 'timeFrame': '30 days after vaccination', 'description': 'Primary immunogenicity outcome was the proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants and the post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. Otherwise, the subjects are categories as unsusceptible ones.'}], 'secondaryOutcomes': [{'measure': 'Overall seroprotection rate', 'timeFrame': '30 days after vaccination', 'description': 'Overall seroprotection rate was defined as the proportion of subjects with reciprocal titre of at least eight.'}, {'measure': 'Geometric mean of antibody titres (GMT)', 'timeFrame': '30 days after vaccination'}, {'measure': 'Increase of geometric mean of antibody titres (GMI)', 'timeFrame': '30 days after vaccination'}, {'measure': 'Proportion of infants with serious adverse events', 'timeFrame': 'Six months after vaccination'}, {'measure': 'Solicited adverse events', 'timeFrame': '30 days after vaccination', 'description': 'Solicited adverse events involving both systemic reactions (including fever, irritability/fussiness, somnolence, vomit, diarrhea, and allergic reaction) and local reactions (including tenderness, redness, swelling, and callous around the injection sites).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunization', 'vaccine schedule', 'poliomyelitis', 'polio', 'oral polio vaccine', 'inactivated polio vaccine'], 'conditions': ['Poliomyelitis']}, 'descriptionModule': {'briefSummary': 'Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.', 'detailedDescription': 'A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '60 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.\n\nExclusion Criteria:\n\n* Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.'}, 'identificationModule': {'nctId': 'NCT02785705', 'acronym': 'TTbOPV', 'briefTitle': 'Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control'}, 'officialTitle': 'Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine by Comparing Different Poliomyelitis Vaccination Schedules in Chinese Infant: a Randomized Controlled Non-Inferiority Clinical Trial', 'orgStudyIdInfo': {'id': 'Tiantan-201417903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cIPV-bOPV-bOPV poliovirus vaccine', 'description': 'Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially.', 'interventionNames': ['Biological: poliovirus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'cIPV-tOPV-tOPV poliovirus vaccine', 'description': 'Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.', 'interventionNames': ['Biological: poliovirus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'cIPV-cIPV-bOPV poliovirus vaccine', 'description': 'Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially.', 'interventionNames': ['Biological: poliovirus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'cIPV-cIPV-tOPV poliovirus vaccine', 'description': 'Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.', 'interventionNames': ['Biological: poliovirus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'cIPV-cIPV-cIPV poliovirus vaccine', 'description': 'Participants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine.', 'interventionNames': ['Biological: poliovirus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'tOPV-tOPV-tOPV poliovirus vaccine', 'description': 'Participants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine .', 'interventionNames': ['Biological: poliovirus vaccine']}], 'interventions': [{'name': 'poliovirus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['bivalent types 1 and 3 oral poliovirus vaccine', 'trivalent conventional inactivated poliovirus vaccine', 'trivalent types 1, 2 and 3 oral poliovirus vaccine'], 'description': 'Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.', 'armGroupLabels': ['cIPV-bOPV-bOPV poliovirus vaccine', 'cIPV-cIPV-bOPV poliovirus vaccine', 'cIPV-cIPV-cIPV poliovirus vaccine', 'cIPV-cIPV-tOPV poliovirus vaccine', 'cIPV-tOPV-tOPV poliovirus vaccine', 'tOPV-tOPV-tOPV poliovirus vaccine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhaojun Mo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Biological Products Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhaojun Mo', 'investigatorAffiliation': 'Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control'}}}}