drugset / Trial / NCT04436133
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
Phase 2
Completed
480 enrolled
National Vaccine and Serum Institute, China
Beijing Kantorico Statistical Technology Co., Ltd. · collabChengdu Institute of Biological Products Co.,Ltd. · collabGuangxi Center for Disease Control and Prevention · collabSimoon Record Pharma Information Consulting Co., Ltd. · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
Timeline
- Start
- 2020-06-20
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Vaccine | 270 ug | Intramuscular |
| Comparator | Gardasil 9 | Vaccine | 270 ug | Intramuscular |