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This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.
The following items will be investigated as priority investigation items. <Priority investigation items>
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who receive Arepanrix® | Subjects who receive Arepanrix® as per routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arepanrix® | Biological | Injected according to the prescribing information in the locally approved label by the authorities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of recipients who have adverse reactions after injection | 29 days | |
| The number of recipients who have post-vaccination adverse events after injection | 29 days | |
| The number of recipients who have allergic reactions after injection | 29 days | |
| The number of recipients who have anaphylaxis after injection | 29 days |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese subjects who receive Arepanrix® intramuscular injection for the first time
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C568072 | arepanrix |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |