Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Ch
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .
| Condition(s) | Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN3, VaIN1, VaIN2, VaIN3, Genital Wart, VIN 1, VIN 2, VIN 3, AIS |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years . |
| Who can participate | Inclusion Criteria: (If the "\*" option is not met during screening, the visit can be rescheduled) * Chinese women aged 20-45 who can provide legal identification and have a sexual life history; * The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent; * Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements; * Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal; * \*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of va |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Shanghai Bovax Biotechnology Co., Ltd. |
| Locations | Liuzhou, Guangxi, China |
| Start date | 2020-04-28 |
| NCT ID | NCT04422366 |
| Official listing | https://clinicaltrials.gov/study/NCT04422366 |