Safety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
KOMNAS PP-KIPI
No Registry
INA-MCCLRWE
Tanggal Input Registry : 27-09-2021

02-09-2021
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Local reaction and systemic events occurring within 30 minutes after each immunization.
 
Safety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi)
SSafety Profile Following Inactivated COVID19 Vacine in Healthy Adults Aged >18 Years in Indonesia (Notifikasi)
Interventional
Inactivated COVID-19 Vaccine
1100
 

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 trial

Exclusion 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"
 
KET-361/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
COVID19-0421
Dr. Julitasari Sundoro, dr., MSc-PH