Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:49 AM
Study NCT ID:
NCT05431933
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2001}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate reaction', 'timeFrame': '30 minutes after each vaccination', 'description': 'Any side effects that occur within 30 minutes after the vaccination'}, {'measure': 'Solicited adverse event', 'timeFrame': '7 days after each vaccination', 'description': 'Expected local or systemic side effects after vaccination'}, {'measure': 'Unsolicited adverse event', 'timeFrame': '28 days after each vaccinations', 'description': 'All unwanted or bad events after vaccination other than solicited adverse event'}], 'secondaryOutcomes': [{'measure': 'Seroprotection rate', 'timeFrame': '4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group', 'description': 'Proportion of infants who have more than 8 protective antibody titers'}, {'measure': 'Geometric mean titers of neutralizing antibody against polio antigens', 'timeFrame': '4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group', 'description': 'Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3'}, {'measure': 'Priming response', 'timeFrame': '7 days after the boosting vaccination in the 4 Eupolio group', 'description': 'Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.'}, {'measure': 'Seroconversion rate', 'timeFrame': '4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group', 'description': 'Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Poliomyelitis', 'Vaccine Reaction']}, 'descriptionModule': {'briefSummary': "Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated.\n\nAs IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants in stable health\n* Male or female 6 to 8 weeks of age\n* Signed informed consent by the infant's parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known or suspected poliomyelitis\n* Known or suspected febrile(symptom of a fever), or chronic illnesses\n* Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever\n* Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)\n* Previous use of blood or blood-derived products\n* Previous use of polio vaccines\n* Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)\n* Bleeding disorders\n* Household contact or intimate exposure with a confirmed case of polio\n* Any history of allergy (hypersensitivity) to the components of the polio vaccine\n* Participation in another interventional clinical trial simultaneously or within 30 days"}, 'identificationModule': {'nctId': 'NCT05431933', 'briefTitle': "Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants", 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants', 'orgStudyIdInfo': {'id': 'LG-VCCL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety group', 'description': 'Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.', 'interventionNames': ['Biological: Eupolio']}, {'type': 'EXPERIMENTAL', 'label': 'Immunogenicity group 1 (4 Eupolio including 1 boosting dose)', 'description': 'Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.', 'interventionNames': ['Biological: Eupolio']}, {'type': 'EXPERIMENTAL', 'label': 'Immunogenicity group 2 (3bOPV+2 Eupolio)', 'description': 'bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.', 'interventionNames': ['Biological: Eupolio']}], 'interventions': [{'name': 'Eupolio', 'type': 'BIOLOGICAL', 'description': 'Inactivated Polio vaccine (Sabin strains)', 'armGroupLabels': ['Immunogenicity group 1 (4 Eupolio including 1 boosting dose)', 'Immunogenicity group 2 (3bOPV+2 Eupolio)', 'Safety group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cavite City', 'country': 'Philippines', 'facility': 'Health Index Multispecialty and Lying-in Clinic', 'geoPoint': {'lat': 14.48369, 'lon': 120.89878}}, {'city': 'Gov, D, Nabgybat Ave', 'country': 'Philippines', 'facility': 'De La Salle Medical and Health Sciences Institue'}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'University of the Philippines - Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Metro Manila', 'country': 'Philippines', 'facility': 'Tropical Disease Foundateion, Inc.'}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Philippine Heart Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University, Srinagarind Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Hatyai Hospital', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}