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| Name | Class |
|---|---|
| C&R Research, Inc. | INDUSTRY |
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The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE | Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIKEVAX Bivalent BA.1 | Biological | No study drug will be administered during this study as this is an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AEs | Up to 28 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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The population of this survey is Korean participants vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, and SPIKEVAX JN.1 who meet the inclusion/exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonseimin Clinic | Wŏnju | Gangwon-do | 26428 | South Korea | ||
| Hyundai Clinic |
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|
| SPIKEVAX Bivalent BA.4/5 | Biological | No study drug will be administered during this study as this is an observational study. |
|
|
| SPIKEVAX XBB.1.5 | Biological | No study drug will be administered during this study as this is an observational study. |
|
|
| SPIKEVAX JN.1 | Biological | No study drug will be administered during this study as this is an observational study. |
|
|
| Bucheon-si |
| Gyeonggi-do |
| 14483 |
| South Korea |
| Ma Hak ki Family Medicine Clinic | Bucheon-si | Gyeonggi-do | 14614 | South Korea |
| Nalee Hospital | Gimpo-si | Gyeonggi-do | 10108 | South Korea |
| COA ENT Clinic | Goyang-si | Gyeonggi-do | 10234 | South Korea |
| Joon Pediatric Clinic | Gwangmyeong | Gyeonggi-do | 14250 | South Korea |
| Janghyeon Medicine Clinic | Namyangju | Gyeonggi-do | 14998 | South Korea |
| Jeong's Family Medical Clinic | Siheung | Gyeonggi-do | 15065 | South Korea |
| Hanyang Union Rehabilitation Medicine Clinic | Yangju | Gyeonggi-do | 11404 | South Korea |
| KimHyungjoo Clinic | Yangju | Gyeonggi-do | 11456 | South Korea |
| Kium Children Hospital | Gunsan | Jeollabuk-do | 54072 | South Korea |
| Sinsegie ENT Clinic | Busan | 48111 | South Korea |
| Bupyeong Yonsei Medical Clinic | Incheon | 21405 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Woori Medical Clinic | Seoul | 01684 | South Korea |
| Yonsei Kids Pediatrics Clinic | Seoul | 01851 | South Korea |
| Star Pediatrics Clinic | Seoul | 03912 | South Korea |
| Seoul Bon Clinic | Seoul | 04032 | South Korea |
| Dr Cho's Family Medical Clinic | Seoul | 05351 | South Korea |
| Songpa Korea Neurosurgical Clinic | Seoul | 05769 | South Korea |
| GF Pediatrics Clinic | Seoul | 06568 | South Korea |
| Kim Il Joong Internal Medicine Clinic | Seoul | 06727 | South Korea |
| New Yonsei ENT Clinic | Seoul | 07327 | South Korea |
| Gangseo HANA ENT | Seoul | 07774 | South Korea |
| Kim's Pediatrics Clinic | Seoul | 08652 | South Korea |
| Soo Orthopedics Clinic | Seoul | 08701 | South Korea |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |
| 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 |
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