Trials / Completed
CompletedNCT04083196
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- National Vaccine and Serum Institute, China · Industry
- Sex
- Female
- Age
- 9 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A total of 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45 years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Injection vaccine produced by ChinaVaccineSerum ,containing HPV antigen protein, 270μg/1ml/bottle |
| BIOLOGICAL | Placebo | Placebo |
Timeline
- Start date
- 2019-09-07
- Primary completion
- 2021-10-13
- Completion
- 2021-10-13
- First posted
- 2019-09-10
- Last updated
- 2021-11-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04083196. Inclusion in this directory is not an endorsement.