Spots Global Cancer Trial Database for Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
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Trial Identification
Brief Title: Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
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
Study ID: NCT04965350
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 9 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Mianyang Center for Disease Control and Prevention, Mianyang, Sichuan, China
Contact Details
Name: Ting Huang
Affiliation: Sichuan Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
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