drugset / Trial / NCT05680454
A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine
Phase 1
Completed
160 enrolled
Beijing Health Guard Biotechnology, Inc
Jiangsu Province Centers for Disease Control and Prevention · collabNanjing Sangruisi Pharmaceutical Technology Co., Ltd · collabNational Institutes for Food and Drug Control, China · collabSchool of Public Health of Southeastern University · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45
Timeline
- Start
- 2019-09-01
- Primary completion
- 2020-04-06
- Completion
- 2022-05-10
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 | 220 ug | — |
| Subject | Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) | Vaccine | 270 ug | — |
| Subject | Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) | Vaccine | 360 ug | — |
| Comparator | Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine | Vaccine | 270 ug | — |