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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 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | Experimental | 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha),0.5mL, three doses, 0,2,6 months |
|
| GARDASIL ®9 | Active Comparator | GARDASIL®9 (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) ,0.5mL, three doses, 0,2,6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | Biological | 9vHPV vaccine ,0.5mL, three doses, 0,2,6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of neutralizing antibodies | The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58. | 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects | To evaluate the vaccine immunogenicity is the geometric mean titer from 30 days after the last dose to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58. | 30 days after the last dose |
| The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination |
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Inclusion Criteria:
(If the "*" option is not met during screening, the visit can be rescheduled)
Exclusion Criteria:
First dose exclusion criteria(If the "*" option is met during screening, the visit can be rescheduled)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention | Guangxi | China |
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Parallel Assignment
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Double (Participant, Investigator)
| Active Comparator: GARDASIL ®9 | Biological | GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months |
|
The growth rate of GMTs of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in pre-immune positive subjects from 30 days after immunization |
| 30 days after the last dose |
| Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination | The seroconversion rate (4-fold increase) of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in subjects aged 16-26-year-old from 30 days after immunization | 30 days after the last dose |
| Number of AE within 30 minutes after each dose | Adverse events reported within 30 minutes after each dose | 30 mins after each dose |
| Number of SAE within 7days after each dose | Solicited adverse events reported between day 0 to day 7 after each dose | day 0 to day 7 after each dose |
| Number of unsolicited adverse events within 30days after each dose | Unsolicited adverse events reported between day 0 to day 30 after each dose | day 0 to day 30 after each dose |
| Number of all SAE during the study period | Serious adverse events reported during the study periodfrom 1st vaccination to the completion of study | Day 0 to 6 months post vaccination 3 |
| Number and rate of pregnancy events | Pregnant event and pregnant outcome reported during the study period | Day 0 to 6 months post vaccination 3 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
| 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 |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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