Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05262010
PHASE3

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

Sponsor: National Vaccine and Serum Institute, China

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

13500

Start Date

2022-06-04

Completion Date

2028-06

Last Updated

2026-01-16

Healthy Volunteers

Yes

Interventions

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

Locations (8)

Hechi Yizhou District Center for Disease Control and Prevention

Hechi, Guangxi, China

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, China

Lianyuan Center for Disease Control and Prevention

Lianyuan, Hunan, China

Qiyang Center for Disease Control and Prevention

Wuxi, Hunan, China

Yongji Center for Disease Control and Prevention

Yongji, Shanxi, China

Yuanqu Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Mianyang Youxian District Center for Disease Control and Prevention

Mianyang, Sichuan, China

Neijiang Shizhong District Center for Disease Control and Prevention

Neijiang, Sichuan, China