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Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Ting Huang

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.

Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females

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

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.

Yuxi Zerun Biotechnology Co., Ltd.

Shanghai Zerun Biotechnology Co.,Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females	NCT04965350	HPV Infection	Recombinant Hum...	9 Years - 30 Years	Shanghai Zerun Biotechnology Co.,Ltd
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females	NCT04965350	HPV Infection	Recombinant Hum...	9 Years - 30 Years	Shanghai Zerun Biotechnology Co.,Ltd
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females	NCT04965350	HPV Infection	Recombinant Hum...	9 Years - 30 Years	Shanghai Zerun Biotechnology Co.,Ltd

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