Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia

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

02-09-2021
To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization
- To assess systemic reaction after COVID-19 Vaccine immunization - To assess local reaction after COVID-19 Vaccine immunization - To assess any serious adverse event after COVID-19 Vaccine immunization
 
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Observasional
N/A
1100
 

Inclusion Criteria:

1. Clinically healthy adults aged > 18 years. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. Evolving mild, mode rate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer). 3. Women who are lactating, pregnant or planning to become pregnant during the study period. 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 5. 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)). 6. Subjects receive any vaccination within 1 month before and after IP immunization. 7. Subjects plan to move from the study area before the end of study period.
 
S-626/UN2.F1/ETIK/PPM.00.02/2021
N/A
B-RG.01.06.32.323.08.21.439
COVID19-0421
Dr. Julitasari Sundoro, dr., MSc-PH