This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
488
Three doses administered intramuscularly at 0, 45 day and 6 month.
Three doses administered intramuscularly at 0, 45 day and 6 month.
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level
Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7
Time frame: 7 months after the first dose
safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Time frame: During the 7-day period following each vaccination
safety2:Adverse events/reactions occurred within 30 days after each vaccination.
Adverse events/reactions occurred within 30 days after each vaccination.
Time frame: Within 30 days (Day 0-30) after any vaccination
safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.
Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.
Time frame: Up to 8 month
safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.
Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.
Time frame: Up to 8 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.