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Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

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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

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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