Clinical Trial: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old
Study Status: Completed
Recruit Status: RECRUITING
Condition: COVID-19 Pandemic
Study Type: INTERVENTIONAL
Official Title: An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old
Brief Summary:
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.
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