Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination
- Conditions
- COVID-19
- Registration Number
- NCT06690502
- Lead Sponsor
- PT Bio Farma
- Brief Summary
This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1208
- Clinically healthy subjects aged 18 years and above
- Subjects have been injected with IndoVac booster.
- Minimum 6-month interval from primary or booster COVID-19 vaccination.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
- Subject's telephone number is invalid or cannot be contacted.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serious adverse event following IndoVac booster vaccination until 30 minutes after each dose Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination
- Secondary Outcome Measures
Name Time Method 0-7 Days Reactions Within 0-7 Days after each dose Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.
8-28 Days Reactions Within 8-28 Days after each dose Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.
28 Days Reactions 28 Days after each dose Number and percentage of any serious adverse event after IndoVac booster vaccination
Trial Locations
- Locations (28)
Gambir Public Health Center
🇮🇩Jakarta, Center Jakarta, Indonesia
Kemayoran Public Health Center
🇮🇩Jakarta, Center Jakarta, Indonesia
Menteng Public Health Center
🇮🇩Jakarta, Center Jakarta, Indonesia
Sawah Besar Public Health Center
🇮🇩Jakarta, Center Jakarta, Indonesia
Tanah Abang Public Health Center
🇮🇩Jakarta, Center Jakarta, Indonesia
Cakung Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Cipayung Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Ciracas Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Makasar Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Matraman Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Pulogadung Public Health Center
🇮🇩Jakarta, East Jakarta, Indonesia
Cilincing Public Health Center
🇮🇩Jakarta, North Jakarta, Indonesia
Kelapa Gading Public Health Center
🇮🇩Jakarta, North Jakarta, Indonesia
Koja Public Health Center
🇮🇩Jakarta, North Jakarta, Indonesia
Pademangan Public Health Center
🇮🇩Jakarta, North Jakarta, Indonesia
Cilandak Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Jagakarsa Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Kebayoran Baru Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Mampang Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Pancoran Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Pesanggrahan Public Health Center
🇮🇩Jakarta, South Jakarta, Indonesia
Cengkareng Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia
Grogol Petamburan Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia
Kebon Jeruk Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia
Imunicare Bio Farma
🇮🇩Bandung, West Java, Indonesia
Kalideres Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia
Kembangan Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia
Palmerah Public Health Center
🇮🇩Jakarta, West Jakarta, Indonesia