Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan, China
NCT Number: NCT04965350
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
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Notify Me9 year–30 year
Female
Interventional
Phase 3
Mianyang, Sichuan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sterile solution for intramuscular injection
Time frame: At Month 7
Time frame: At Month 7
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: 0~30 days after each vaccination
Time frame: 0~7 days after each vaccination
Time frame: 0~30 days after each vaccination
Time frame: Month 0 to Month 7
Shanghai Zerun Biotechnology Co.,Ltd
Industry
A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale
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