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

PT Bio Farma

Status: Completed

Conditions: Safety Issues

Study type: Observational

Funder types: Industry

Identifiers

NCT05037227

COVID19-0421

Details and patient eligibility

About

The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.

Full description

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.

Enrollment: 1,100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.