Safety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi)
Tahapan Penelitian : Complete
Sponsor:
PT Bio Farma (Persero)
Mitra Pelaksana:
KOMNAS PP-KIPI
No Registry
INA-MCCLRWE
Tanggal Input Registry : 27-09-2021
Tracking Information | |
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Tanggal Antisipasi Studi | 02-09-2021 |
Outcome Primer | Any serious adverse event occurring from inclusion until 30 minutes after the injection |
Outcome Skunder | Local reaction and systemic events occurring within 30 minutes after each immunization. |
Descriptive Information | |
Judul Penelitian Popular | Safety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi) |
Judul Penelitian Ilmiah | SSafety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi) |
Jenis Penelitian | Interventional |
Intervensi | Inactivated COVID-19 Vaccine |
Jumlah Subyek Penelitian | 1100 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Clinically healthy adults aged > 18 years, Subjects have been informed properly regarding the study and signed the informed consent form, Subjects will commit to comply with the instructions of the investigator and the schedule of the trialExclusion Criteria: "Subjects concomitantly enrolled or scheduled to be enrolled in another trial, Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer), Women who are lactating, pregnant or planning to become pregnant during the study period, History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, 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)), Subjects receive any vaccination within 1 month before and after IP immunization, Subjects plan to move from the study area before the end of study period" |
Administrative Information | |
Nomor Persetujuan Etik | KET-361/UN2.F1/ETIK/PPM.00.02/2021 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | COVID19-0421 |
Contact Person | Dr. Julitasari Sundoro, dr., MSc-PH |