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This study is designed to evaluate the vaccine efficacy, immunogenicity and safety 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 20-45 Years .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 | 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 |
|---|---|---|---|---|
| 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) | Biological | Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| Measure | Description | Time Frame |
|---|---|---|
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 | |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 |
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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)
Second and third doses of vaccine were excluded criteria
Second and third doses of vaccine were delayed criteria
Vaccination may be postponed if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Mo, Master | Contact | +8613788686968 | moyi0415@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou center for disease control and prevention | Recruiting | Liuzhou | Guangxi | China |
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| GARDASIL® | Biological | Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule |
|
| 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| 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 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study | 1 month post vaccination 3 (Month 7) up to Month 84 |
| neutralizing antibody level | 30 days post third dose of vaccination |
| 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 |
|---|---|
| D014614 | Vaccines, Synthetic |
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D017778 | Vaccines, Combined |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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