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This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1000 subjects receive the HPV 4 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV 4 | Biological | 1000 subjects will be received the HPV 4 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice | Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy | 24 months |
| Number of participants with adverse events following any dose of vaccine | Number of participants with adverse events following any dose of vaccine | within 30 days after each dose |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers aged 20-45 years
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |