drugset / Trial / NCT04965350
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
Phase 3
Completed
1100 enrolled
Shanghai Zerun Biotechnology Co.,Ltd
Yuxi Zerun Biotechnology Co., Ltd. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) | Vaccine | — | Intramuscular |