drugset / Trial / NCT04083196
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Phase 1
Completed
90 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 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45 years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients. 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
- 2019-09-07
- Primary completion
- 2021-10-13
- Completion
- 2021-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Vaccine | 270 ug | Intramuscular |