Official Title
Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
Brief Summary

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

Detailed 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.

Completed
COVID-19
Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Gambir Public Health Center
Jakarta 1642911, Center Jakarta, Indonesia

Kemayoran Public Health Center
Jakarta 1642911, Center Jakarta, Indonesia

Menteng Public Health Center
Jakarta 1642911, Center Jakarta, Indonesia

Sawah Besar Public Health Center
Jakarta 1642911, Center Jakarta, Indonesia

Tanah Abang Public Health Center
Jakarta 1642911, Center Jakarta, Indonesia

Cakung Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Cipayung Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Ciracas Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Makasar Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Matraman Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Pulogadung Public Health Center
Jakarta 1642911, East Jakarta, Indonesia

Cilincing Public Health Center
Jakarta 1642911, North Jakarta, Indonesia

Kelapa Gading Public Health Center
Jakarta 1642911, North Jakarta, Indonesia

Koja Public Health Center
Jakarta 1642911, North Jakarta, Indonesia

Pademangan Public Health Center
Jakarta 1642911, North Jakarta, Indonesia

Cilandak Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Jagakarsa Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Kebayoran Baru Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Mampang Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Pancoran Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Pesanggrahan Public Health Center
Jakarta 1642911, South Jakarta, Indonesia

Cengkareng Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Grogol Petamburan Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Kalideres Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Kebon Jeruk Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Kembangan Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Palmerah Public Health Center
Jakarta 1642911, West Jakarta, Indonesia

Imunicare Bio Farma
Bandung 1650357, West Java 1642672, Indonesia

Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed, Principal Investigator
National Committee of Adverse Events Following Immunization / NC Indonesia

NCT Number
Keywords
Covid-19
IndoVac
Safety Vaccine
MeSH Terms
COVID-19