Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
NCT Number: NCT04782895
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.
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Notify Me18 year–26 year
Female
Interventional
Phase 3
Nanjing, Jiangsu, 210009, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three doses administered intramuscularly at 0, 45 day and 6 month.
Three doses administered intramuscularly at 0, 45 day and 6 month.
Time frame: 7 months after the first dose
Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7
Time frame: During the 7-day period following each vaccination
Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Time frame: Within 30 days (Day 0-30) after any vaccination
Adverse events/reactions occurred within 30 days after each vaccination.
Time frame: Up to 8 month
Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.
Time frame: Up to 8 month
Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.
Time frame: 7 months after the first dose
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at months 7(type specific IgG antibody)
Xiamen University
Other
A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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