Trials / Completed
CompletedNCT05372016
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the 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 Aged16-26 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (actual)
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd. · Industry
- Sex
- Female
- Age
- 16 Years – 26 Years
- Healthy volunteers
- Accepted
Summary
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
Conditions
- HPV Infections
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- CIN1
- CIN2
- CIN3
- VaIN1
- VaIN2
- VaIN3
- Genital Wart
- VIN 1
- VIN 2
- VIN 3
- AIS
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | 9vHPV vaccine ,0.5mL, three doses, 0,2,6 months |
| BIOLOGICAL | Active Comparator: GARDASIL ®9 | GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months |
Timeline
- Start date
- 2020-09-19
- Primary completion
- 2022-06-17
- Completion
- 2022-06-17
- First posted
- 2022-05-12
- Last updated
- 2023-11-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05372016. Inclusion in this directory is not an endorsement.