Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-10 @ 4:56 PM
Study NCT ID:
NCT05546502
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Vaccine candidate and active comparator are masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Vaccine candidate and active comparator are masking'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1050}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series', 'timeFrame': '14 days after primary series', 'description': 'Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series'}], 'secondaryOutcomes': [{'measure': 'To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.', 'timeFrame': '14 days after primary series', 'description': 'Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination.'}, {'measure': 'To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).', 'timeFrame': '28 days after each dose', 'description': 'Local reactions and systemic events'}, {'measure': 'To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).', 'timeFrame': '12 months after primary series', 'description': 'Serious Adverse Event'}, {'measure': 'To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.', 'timeFrame': '28 days after each dose', 'description': 'local reactions, systemic events'}, {'measure': 'To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.', 'timeFrame': '28 days after each dose', 'description': 'SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody'}, {'measure': 'To evaluate antibody persistence 3, 6 and 12 months after primary series', 'timeFrame': '3, 6 and 12 months after primary series', 'description': 'SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccine Reaction', 'Vaccine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'A Phase III, Observer-blind, randomized, active-controlled prospective intervention study', 'detailedDescription': 'This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.\n\nThe subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.\n\nMain Study for immunogenicity and safety evaluation.\n\nExploratory Study for cellular immunity evaluation,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinically healthy children aged 12-17 years.\n2. Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).\n3. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.\n2. History of vaccination with any COVID-19 vaccine (based on anamnesis).\n3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).\n4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).\n5. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.\n6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n7. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.\n8. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\\> 2 weeks)).\n9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.\n10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.\n11. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).\n\n11\\. Subjects plan to move from the study area before the end of study period.'}, 'identificationModule': {'nctId': 'NCT05546502', 'briefTitle': 'Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia', 'orgStudyIdInfo': {'id': 'CoV2-Children-0322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVID-19 Protein Subunit Recombinant Vaccine', 'description': '2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)', 'interventionNames': ['Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': '2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)', 'interventionNames': ['Biological: Active Comparator']}], 'interventions': [{'name': 'SARS-CoV-2 Protein Subunit Recombinant Vaccine', 'type': 'BIOLOGICAL', 'description': 'SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma', 'armGroupLabels': ['COVID-19 Protein Subunit Recombinant Vaccine']}, {'name': 'Active Comparator', 'type': 'BIOLOGICAL', 'description': 'Covovax', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Bali Mandara Hospital', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Universitas Udayana Hospital', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'city': 'Banjarnegara', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'RSUD Hj. Anna Lasmanah', 'geoPoint': {'lat': -7.35944, 'lon': 109.47}}, {'city': 'Bandar Lampung', 'state': 'Lampung', 'country': 'Indonesia', 'facility': 'Abdoel Moeloek Hospital', 'geoPoint': {'lat': -5.42917, 'lon': 105.26111}}, {'city': 'Bogor', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Rumpin Primary Health Care', 'geoPoint': {'lat': -6.59444, 'lon': 106.78917}}, {'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Duren Seribu Primary Health Care', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}, {'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Pasir Putih Primary Health Care', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}, {'city': 'Mataram', 'state': 'West Nusa Tenggara', 'country': 'Indonesia', 'facility': 'Universitas Mataram Hospital', 'geoPoint': {'lat': -8.58333, 'lon': 116.11667}}, {'city': 'Padang', 'state': 'West Sumatra', 'country': 'Indonesia', 'facility': 'M Djamil Hospital', 'geoPoint': {'lat': -0.94924, 'lon': 100.35427}}, {'city': 'Padang', 'state': 'West Sumatra', 'country': 'Indonesia', 'facility': 'RS Universitas Andalas', 'geoPoint': {'lat': -0.94924, 'lon': 100.35427}}], 'overallOfficials': [{'name': 'Cahya Satria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CC PRO UGM'}, {'name': 'Bernie Medise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}, {'name': 'Asrawati Asrawati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Universitas Andalas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM', 'class': 'UNKNOWN'}, {'name': 'Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta', 'class': 'UNKNOWN'}, {'name': 'Faculty of Medicine, Andalas University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}