protocolSection identificationModule nctId: NCT06282692, orgStudyIdInfo id: UNAIR-MP-INAKTIF-R-005, briefTitle: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2024-05-19, completionDateStruct date: 2024-07-19, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dr. Soetomo General Hospital, class: OTHER_GOV, collaborators name: Indonesia-MoH, collaborators name: Universitas Airlangga, collaborators name: PT Biotis Pharmaceuticals, Indonesia, descriptionModule briefSummary: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents., conditionsModule conditions: COVID-19 Pandemic, conditions: COVID-19 Vaccines, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval., enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg, outcomesModule primaryOutcomes measure: Vaccine Neutralizing Antibody Profile, secondaryOutcomes measure: Incidence of Adverse Events, secondaryOutcomes measure: Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum, secondaryOutcomes measure: Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA, secondaryOutcomes measure: Cellular Immunogenicity Profile, secondaryOutcomes measure: Persistence of Antibody Level, secondaryOutcomes measure: Whole Genome Sequencing (WGS) of SARS-CoV-2, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Dr. Soetomo General Hospital, status: RECRUITING, city: Surabaya, state: Jawa Timur, zip: 67161, country: Indonesia, contacts name: Dominicus Husada, MD, role: CONTACT, phone: +6281232266377, email: dominicushusada@yahoo.com, contacts name: Damayanti Tinduh, MD, role: CONTACT, phone: +6281703293335, email: damayanti.tinduh@fk.unair.ac.id, contacts name: Dominicus Husada, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Damayanti Tinduh, MD, role: SUB_INVESTIGATOR, contacts name: Gatot Soegiarto, MD, role: SUB_INVESTIGATOR, contacts name: Leny Kartina, MD, role: SUB_INVESTIGATOR, contacts name: Laksmi Wulandari, MD, role: SUB_INVESTIGATOR, contacts name: Deasy Fetarayani, MD, role: SUB_INVESTIGATOR, contacts name: Novira Widajanti, MD, role: SUB_INVESTIGATOR, contacts name: Yudi H Oktaviano, MD, role: SUB_INVESTIGATOR, contacts name: Aryati Aryati, MD, role: SUB_INVESTIGATOR, contacts name: Fitriah Munawaroh, MD, role: SUB_INVESTIGATOR, contacts name: Neneng D Kurniati, MD, role: SUB_INVESTIGATOR, contacts name: Budi Utomo, MD, role: SUB_INVESTIGATOR, contacts name: Eko B Khoendori, MD, role: SUB_INVESTIGATOR, contacts name: Jusak Nugroho, MD, role: SUB_INVESTIGATOR, contacts name: Maria I Lusida, MD, role: SUB_INVESTIGATOR, geoPoint lat: -7.24917, lon: 112.75083, hasResults: False