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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
8,000
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule
Liuzhou center for disease control and prevention
Liuchow, Guangxi, China
RECRUITINGThe 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
Time frame: 1 month post vaccination 3 (Month 7) 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 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 minutes post any vaccination
Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination
Time frame: 7 days post any vaccination
Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination
Time frame: 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
Time frame: 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
Time frame: 1 month post vaccination 3 (Month 7) up to Month 84
neutralizing antibody level
Time frame: 30 days post third dose of vaccination
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