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This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IndoVac COVID-19 Vaccine | Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse event following IndoVac booster vaccination | Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination | until 30 minutes after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| 0-7 Days Reactions | Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination. | Within 0-7 Days after each dose |
| 8-28 Days Reactions |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adults aged 18 years and above
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| Name | Affiliation | Role |
|---|---|---|
| Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed | National Committee of Adverse Events Following Immunization / NC Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gambir Public Health Center | Jakarta | Center Jakarta | Indonesia | |||
| Kemayoran Public Health Center |
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Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.
| Within 8-28 Days after each dose |
| 28 Days Reactions | Number and percentage of any serious adverse event after IndoVac booster vaccination | 28 Days after each dose |
| 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 |
| Kalideres Public Health Center | Jakarta | West Jakarta | Indonesia |
| Kebon Jeruk Public Health Center | Jakarta | West Jakarta | Indonesia |
| Kembangan Public Health Center | Jakarta | West Jakarta | Indonesia |
| Palmerah Public Health Center | Jakarta | West Jakarta | Indonesia |
| Imunicare Bio Farma | Bandung | West Java | Indonesia |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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