NCT04965350

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd · Industry
• Sex: Female
• Age: 9 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• HPV Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)	sterile solution for intramuscular injection

Timeline

• Start date: 2021-04-20
• Primary completion: 2022-04-27
• Completion: 2022-05-16
• First posted: 2021-07-16
• Last updated: 2023-04-13

Locations

1 site across 1 country: China