NCT05262010

A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 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 9-45 Years

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,500 (estimated)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HPV InfectioN
• HPV-Related Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
BIOLOGICAL	placebo	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Timeline

• Start date: 2022-06-04
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2022-03-02
• Last updated: 2026-01-16

Locations

8 sites across 1 country: China