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| Name | Class |
|---|---|
| Chongqing Bovax Biopharmaceutical Co., Ltd. | INDUSTRY |
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The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-valent HPV Vaccine | Experimental | Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha) |
|
| 9-valent HPV Vaccine | Experimental | Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) |
|
| GARDASIL® | Active Comparator | Participants in this arm would receive GARDASIL® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-valent HPV Vaccine | Biological | Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) | |
| Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangchun Center For Disease Prevention And Control | Yangchun | Guangdong | China |
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| 9-valent HPV Vaccine | Biological | Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. |
|
| GARDASIL® | Biological | Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule. |
|
| 1 month post vaccination 3 (Month 7) |
| Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) |
| The neutralizing antibody GMTs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) |
| Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) |
| Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3. | 1 month post vaccination 3 (Month 7) |
| Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination | 30 minutes post any vaccination |
| Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination | 7 days post any vaccination |
| Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination | 30 days post any vaccination |
| Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study | Day 1 to 6 months post vaccination 3 |
| Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study | Day 1 to 6 months post vaccination 3 |
| 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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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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