drugset / Trial / NCT05668572
A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine
RandomizedParallel-groupDouble-blindPrevention
Summary
This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer or anal cancer.
Timeline
- Start
- 2020-12-05
- Primary completion
- 2022-07-21
- Completion
- 2023-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) | Vaccine | 0.5 ml | Other |
| Comparator | Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®） | Vaccine | 0.5 ml | Other |