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| Name | Class |
|---|---|
| National Advisory Immunization Committee Indonesia | UNKNOWN |
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This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine
This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderna COVID-19 Vaccine | Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderna COVID-19 Vaccine | Biological | Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Reactions Following Moderna COVID-19 Vaccine | Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine. | 28 Days after each dose |
| Systemic Reactions Following Moderna COVID-19 Vaccine | Percentage of subject with systemic reactions following immunization with Moderna COVID-19 | 28 Days after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Reactions | percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. | 30 minutes after each dose |
| 1-3 Days Reactions | percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
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Healthy adults aged ≥ 18 years
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| Name | Affiliation | Role |
|---|---|---|
| Julitasari Sundoro, MD | National Advisory Immunization Committee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gambir Public Health Center | Jakarta Pusat | Jakarta Special Capital Region | 10130 | Indonesia | ||
| Johar Baru Public Health Center |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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|
| 1-3 minutes after each dose |
| 4-7 Days Reactions | percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. | 4-7 Days after each dose |
| 8-28 Days Reactions | percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine. | 8-28 Days after each dose |
| Serious Reactions | Any serious adverse events following immunization with Moderna COVID-19 vaccine | 28 Days after each dose |
| Jakarta Pusat |
| Jakarta Special Capital Region |
| 10560 |
| Indonesia |
| Cempaka Putih Public Health Center | Jakarta Pusat | Jakarta Special Capital Region | 10570 | Indonesia |
| Kemayoran Public Health Center | Jakarta Pusat | Jakarta Special Capital Region | 10640 | Indonesia |
| Palmerah Public Health Center | Jakarta | 11480 | Indonesia |
| Kebon Jeruk Public Health Center | Jakarta | 11530 | Indonesia |
| Cengkareng Public Health Center | Jakarta | 11730 | Indonesia |
| Kebayoran Lama Public Health Center | Jakarta | 12240 | Indonesia |
| Tebet Public Health Center | Jakarta | 12820 | Indonesia |
| Setiabudi Public Health Center | Jakarta | 12980 | Indonesia |
| Pulo Gadung Public Health Center | Jakarta | 13260 | Indonesia |
| Duren Sawit Public Health Center | Jakarta | 13420 | Indonesia |
| Regional Hospital Duren Sawit | Jakarta | 13440 | Indonesia |
| Kramat Jati Public Health Center | Jakarta | 13510 | Indonesia |
| Cilincing Public Health Center | Jakarta | 14120 | Indonesia |
| Koja Public Health Center | Jakarta | 14260 | Indonesia |
| Tanjung Priok Public Health Center | Jakarta | 14310 | Indonesia |
| Pademangan Public Health Center | Jakarta | 14410 | Indonesia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |