A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
13,500
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
Hechi Yizhou District Center for Disease Control and Prevention
Hechi, Guangxi, China
NOT_YET_RECRUITINGHezhou Center for Disease Control and Prevention
Hezhou, Guangxi, China
NOT_YET_RECRUITINGLianyuan Center for Disease Control and Prevention
Lianyuan, Hunan, China
RECRUITINGQiyang Center for Disease Control and Prevention
Wuxi, Hunan, China
RECRUITINGYongji Center for Disease Control and Prevention
Yongji, Shanxi, China
NOT_YET_RECRUITINGYuanqu Center for Disease Control and Prevention
Yuncheng, Shanxi, China
NOT_YET_RECRUITINGMianyang Youxian District Center for Disease Control and Prevention
Mianyang, Sichuan, China
NOT_YET_RECRUITINGNeijiang Shizhong District Center for Disease Control and Prevention
Neijiang, Sichuan, China
NOT_YET_RECRUITINGPerson-years incidence of CIN2+ associated with HPV6/11/16/18.
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18
Time frame: After at least 1 dose of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68
Time frame: After at least 1 dose of vaccine
Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.
Time frame: After at least 1 dose of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time frame: After at least 1 dose of vaccine
AE incidence and severity distribution
Time frame: The first dose of vaccination to within 1 month after the full vaccination
AE incidence and severity distribution
Time frame: 0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days)
SAE incidence
Time frame: During the study,an average of 6 year
Number of pregnant
Time frame: The first dose of vaccination to within 6 months after the full vaccination
Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)
Previous pregnancy, current pregnancy mode, neonatal information
Time frame: The first dose of vaccination to within 6 months after the full vaccination
To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time frame: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time frame: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
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