Phase 3Active, not recruiting
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
- Sponsor
- National Vaccine and Serum Institute, China (Industry)
- Enrollment
- 13,500 planned
- Conditions
- HPV InfectioN; HPV-Related Carcinoma
- Interventions
- 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha); placebo
- Ages
- adults
- Registry
- NCT05262010
Full record on ClinicalTrials.gov
From the registry
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. 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.
Primary outcomes
- Person-years incidence of CIN2+ associated with HPV6/11/16/18.
- Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
History
Primary completion expected
Last registry update
Started
Registered