drugset / Trial / NCT05662020
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China
Phase 3
Active not recruiting
2750 enrolled
Beijing Health Guard Biotechnology, Inc
Mile City Center for Disease Control and Prevention · collabNational Institutes for Food and Drug Control, China · collabQiubei County Center for Disease Control and Prevention · collabShanghai Stem Pharmaceutical Development Co., Ltd. · collabYanshan County Center for Disease Control and Prevention · collabYunnan Center for Disease Control and Prevention · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.
Timeline
- Start
- 2022-03-23
- Primary completion
- 2022-11-07
- Completion
- 2028-03-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gardasil 9 | Vaccine | 0.5 ml | — |
| Subject | Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) | Vaccine | 0.5 ml | — |