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| Name | Class |
|---|---|
| Chongqing Bovax Biopharmaceutical Co., Ltd. | INDUSTRY |
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To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9-valent HPV Recombinant Vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-valent HPV Recombinant Vaccine | Biological | Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events | 7 days after each vaccination | |
| Number of Subjects Reporting Unsolicited Adverse Events | 30 days after each vaccination | |
| Number of Subjects Reporting Serious Adverse Events | 30 days after third dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58 | 30 days after third dose of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | Hanzhou | China |
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| Placebo | Biological | Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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