Trials / Terminated
TerminatedNCT05584332
A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females
A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,131 (actual)
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .
Conditions
- Cervical Cancer
- Genital Wart
- CIN1
- CIN2
- CIN3
- Vain I
- Vain III
- Vin I
- Vin II
- Vin III
- AIS
- VAIN - Vaginal Intraepithelial Neoplasia 2
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) | 0.5 ml injection in 3 dosing regimen |
| BIOLOGICAL | Placebo | 0.5 ml injection in 3 dosing regimen |
Timeline
- Start date
- 2022-12-09
- Primary completion
- 2023-03-23
- Completion
- 2023-03-23
- First posted
- 2022-10-18
- Last updated
- 2023-07-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05584332. Inclusion in this directory is not an endorsement.