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

HPV Infection Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04965350
Study type Interventional
Source Shanghai Zerun Biotechnology Co.,Ltd
Contact
Status Completed
Phase Phase 3
Start date April 20, 2021
Completion date May 16, 2022
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