This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7,372
3 doses at month 0,1 and 6
3 doses at month 0,1 and 6
Cancer Institute & Hospital Chinese Academy of Medical Sciences
Beijing, China
Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection
Time frame: expected 5-6 years
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)
Time frame: expected 2-3 years
Number of Subjects Reporting Solicited Local and General Symptoms
Time frame: Within 7 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Month 7
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: expected 5-6 years
number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18
Time frame: expected 5-6 years
number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection
Time frame: expected 5-6 years
number of subjects with incidence infection associated with HPV-16 and/or HPV-18
Time frame: expected 2-3 years
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7
Time frame: month 7
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