Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

PT Bio Farma

Status: Completed

Conditions: COVID-19

Study type: Observational

Funder types: Industry

Identifiers

NCT06690502

COV19REC-0423

Details and patient eligibility

About

This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination

Full description

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.

Enrollment: 1,208 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Clinically healthy subjects aged 18 years and above
2. Subjects have been injected with IndoVac booster.
3. Minimum 6-month interval from primary or booster COVID-19 vaccination.
4. Subjects have been informed properly regarding the study and signed the informed consent form.

Exclusion criteria

1. Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
2. Subject's telephone number is invalid or cannot be contacted.

Trial design

1,208 participants in 1 patient group

IndoVac COVID-19 Vaccine

Description:

Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination