drugset / Trial / NCT04965350

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

NCT04965350 ↗

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2021-04-20
Primary completion
2022-04-27
Completion
2022-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) Vaccine — Intramuscular