Trials / Completed
CompletedNCT04436133
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
A Randomized, Blind, and Positive Control Design to Evaluate the Immunization Efficacy of 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-26 Years
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 480 (actual)
- Sponsor
- National Vaccine and Serum Institute, China · Industry
- Sex
- Female
- Age
- 18 Years – 26 Years
- Healthy volunteers
- Accepted
Summary
A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle |
| BIOLOGICAL | 9-valent HPV vaccine（Gardasil 9） | Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle |
Timeline
- Start date
- 2020-06-20
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
- First posted
- 2020-06-17
- Last updated
- 2022-05-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04436133. Inclusion in this directory is not an endorsement.