The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
9vHPV vaccine ,0.5mL, three doses, 0,2,6 months
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Guangxi, China
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.
Time frame: 30 days after the last dose
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.
Time frame: 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
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
Time frame: 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
Time frame: 30 days after the last dose
Number of AE within 30 minutes after each dose
Adverse events reported within 30 minutes after each dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 to 6 months post vaccination 3
Number and rate of pregnancy events
Pregnant event and pregnant outcome reported during the study period
Time frame: Day 0 to 6 months post vaccination 3
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