Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 7:36 PM
Study NCT ID:
NCT02093260
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)', 'timeFrame': '2 months', 'description': 'Percentage of subjects with anti HI titer \\>=1:40'}], 'secondaryOutcomes': [{'measure': 'To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)', 'timeFrame': '2 months', 'description': 'Percentage subjects with increasing antibody titer \\>=4 times'}, {'measure': 'To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)', 'timeFrame': '1 months', 'description': 'Percentage of subjects with transition of seronegative to seropositive'}, {'measure': 'To asses the safety of Flubio vaccine', 'timeFrame': '1-2 months', 'description': 'Local and Systemic Reaction following immunization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Flubio Vaccine (Influenza HA)', 'Infants', 'Children', 'Safety', 'Immunogenicity'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29551225', 'type': 'DERIVED', 'citation': 'Soedjatmiko S, Medise BE, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Bachtiar NS, Sari RM. Immunogenicity and safety of a Trivalent Influenza HA vaccine in Indonesian infants and children. Vaccine. 2018 Apr 12;36(16):2126-2132. doi: 10.1016/j.vaccine.2018.02.114. Epub 2018 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)', 'detailedDescription': 'Too see percentage of subjects with HI titer \\>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Parents have been informed properly regarding the study and signed the informed consent form\n* Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial\n\nExclusion Criteria:\n\n* Subjects concomitantly enrolled or scheduled to be enrolled in another trial\n* Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \\>=37oC)\n* Known history of allergy to egg and/or chicken protein or any other component of the vaccines\n* Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection\n* Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\\>2 weeks)).\n* Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.\n* Subjects has been immunized with influenza vaccine within 1 year\n* Subjects receives any vaccination within 1 months before and after immunization of Flubio.'}, 'identificationModule': {'nctId': 'NCT02093260', 'briefTitle': 'Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children', 'orgStudyIdInfo': {'id': 'Influenza 0213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine', 'description': 'Vaccine\n\nFlubio (Influenza HA) vaccine\n\n2 doses for infants and children (6 months - 8 years old)\n\n1 doses for children (9-11 years old)\n\nThe vaccine will be given intramuscularly', 'interventionNames': ['Biological: Vaccine']}], 'interventions': [{'name': 'Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Flubio'], 'description': 'Flubio (Influenza HA) Vaccine\n\nThe vaccine will be given intramuscularly.', 'armGroupLabels': ['Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Jatinegara Primary Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Primary School of SDN 01 Kampung Melayu', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Bernie Endyarni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Child Health, School of Medicine, University of Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}