drugset / Trial / NCT05262010
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Phase 3
Recruiting
13500 enrolled
National Vaccine and Serum Institute, China
Beijing Kantorico Statistical Technology Co., Ltd. · collabCenters for Disease Control and Prevention, China · collabChengdu Institute of Biological Products Co.,Ltd. · collabGuangxi Center for Disease Control and Prevention · collabHunan Provincial Center for Disease Control and Prevention · collabSichuan Center for Disease Control and Prevention · collabSimoon Record Pharma Information Consulting Co., Ltd. · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Timeline
- Start
- 2022-06-04
- Primary completion
- 2028-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Vaccine | — | Intramuscular |