Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-05 @ 8:19 PM
Study NCT ID:
NCT03336593
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The study for subjects 9-40 years of age is randomized, double blind study. While the study for subjects 6 months-8 years of age is open labeled study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 810}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with an anti-influenza titer >= 1:40 HI units', 'timeFrame': '28 days after the last dose immunization', 'description': 'The anti-influenza antibody serological response'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT)', 'timeFrame': '28 days', 'description': 'GMT in all subjects; comparison of GMT between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison of GMT between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old'}, {'measure': 'Percentage of subjects with increasing antibody titer >= 4 times', 'timeFrame': '28 days', 'description': 'Percentage of subjects with increasing antibody titer \\>= 4 times: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old'}, {'measure': 'Percentage of subjects with transition of seronegative to seropositive', 'timeFrame': '28 days', 'description': 'Percentage of subjects with transition of seronegative to seropositive: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old'}, {'measure': 'Percentage of subjects with at least one immediate reaction', 'timeFrame': '30 minutes after each vaccination', 'description': 'Immediate reaction (local reaction or systemic event)'}, {'measure': 'Percentage of subjects with at least one of these adverse events', 'timeFrame': 'within 72 hours, between 72 hours to 28 days after vaccination', 'description': 'At least one of these adverse events, expected or not'}, {'measure': 'Serious adverse event after vaccination', 'timeFrame': '28 days', 'description': 'Serious adverse event occurring from inclusion until 28 days after vaccination.'}, {'measure': 'Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.', 'timeFrame': '28 days', 'description': 'Adverse events occuring until 28 days after vaccination'}, {'measure': 'Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.', 'timeFrame': '28 days', 'description': 'Adverse events occuring until 28 days after vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'referencesModule': {'references': [{'pmid': '37616221', 'type': 'DERIVED', 'citation': 'Fadlyana E, Dhamayanti M, Tarigan R, Prodjosoewojo S, Rahmadi AR, Sari RM, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults. PLoS One. 2023 Aug 24;18(8):e0281566. doi: 10.1371/journal.pone.0281566. eCollection 2023.'}, {'pmid': '31862195', 'type': 'DERIVED', 'citation': 'Dhamayanti M, Tarigan R, Fadlyana E, Prasetyo D, Amalia N, Rusmil VK, Sari RM, Bachtiar NS, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study. Vaccine. 2020 Jan 29;38(5):993-1000. doi: 10.1016/j.vaccine.2019.12.008. Epub 2019 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population', 'detailedDescription': 'To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population.\n\nTo describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Subjects 9 - 40 Years of Age:\n\n* Healthy\n* Properly informed about the study and having signed the informed consent form\n* Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.\n\nInclusion Criteria for Subjects 6 Months - 8 Years of Age:\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* Subject concomitantly enrolled or scheduled to be enrolled in another trial\n* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \\>= 37.5 C )\n* Known history of allergy to egg and or chicken protein or any component of the vaccines\n* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection\n* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\\> 2 weeks).\n* Pregnancy \\& Lactation (Adult)\n* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives\n* Subject already immunized with influenza vaccine within 1 year.\n* Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.'}, 'identificationModule': {'nctId': 'NCT03336593', 'briefTitle': 'Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population', 'orgStudyIdInfo': {'id': 'QIV 0217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QIV batch 1', 'description': '1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'QIV batch 2', 'description': '1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'QIV batch 3', 'description': '1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent Influenza Vaccine', 'description': '1 dose of 0.5 ml of trivalent influenza vaccine', 'interventionNames': ['Biological: Trivalent Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'QIV (subjects 6-35 months)', 'description': '2 dose of 0.25 ml of quadrivalent influenza vaccine', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'QIV (subjects 3-8 years)', 'description': '2 dose of 0.5 ml of quadrivalent influenza vaccine', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}], 'interventions': [{'name': 'Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['QIV'], 'description': '1 or 2 doses of Quadrivalent Influenza Vaccine depends on age', 'armGroupLabels': ['QIV (subjects 3-8 years)', 'QIV (subjects 6-35 months)', 'QIV batch 1', 'QIV batch 2', 'QIV batch 3']}, {'name': 'Trivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['TIV'], 'description': '1 dose of Trivalent Influenza Vaccine', 'armGroupLabels': ['Trivalent Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Garuda Primary Health Center', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Ibrahim Adjie Primary Health Center', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Puter Primary Health Center', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'overallOfficials': [{'name': 'Meita Dhamayanti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasan Sadikin General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}