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This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female subjects | Subjects received Cervarix® as per routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix® | Biological | Administered according to the prescribing information in the locally approved label by the authorities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with solicited local adverse events | Local adverse events: pain, redness, swelling at the vaccination site | 7 days after vaccination |
| The number of subjects with solicited general adverse events | General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash | 7 days after vaccination |
| The number of subjects with unsolicited adverse events | Any symptoms other than specified (local/systemic) symptoms | 30 days after vaccination |
| The number of subjects with serious adverse events | 30 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese women who received Cervarix® for the first time
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |