This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial. This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group. All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits and subjects in the immune persistence subgroup will need to complete 13 on-site visits ; All subjects in the 9-17 years old 3-dose group and the 18-35 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits and subjects in the immune persistence subgroup will need to complete 16 on-site visits
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,800
Two doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0 and 6 months.
Three doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0, 2, and 6 months.
Shanxian Center for Disease Control and Prevention
Heze, Shandong, China
Liaocheng Center for Disease Control and Prevention
Liaocheng, Shandong, China
Daiyue District Center for Disease Control and Prevention
Tai’an, Shandong, China
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric Mean Titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 at 1 month after completion of the vaccination series among participants who were seropositive at baseline (pre-vaccination).
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Proportion of participants with a ≥4-fold rise in neutralizing antibody titers to HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
Seropositivity rate of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
The number of cases of AE(Adverse Event)
Time frame: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs leading to subjects withdrawing from clinical trials
Time frame: From the first vaccination through 1 month after completion of the vaccination series
Distribution of severity of AE
Time frame: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs
Time frame: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
Distribution of severity of AE
Time frame: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
The incidence of SAE
Time frame: From the first vaccination through 6 months after completion of the vaccination series
Collect information about previous pregnancies of pregnant women survey
Such as previous pregnancy, current pregnancy mode, etc
Time frame: From the first vaccination through the end of the study(Approximately 72 months)
Obtain pregnancy outcomes in pregnant subjects survey
Collecting newborn information
Time frame: From the first vaccination through the end of the study(Approximately 72 months)
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