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

NCT05262010 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13500

Last updated 2026-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Simoon Record Pharma Information Consulting Co., Ltd.

    collaborator INDUSTRY

  • Beijing Kantorico Statistical Technology Co., Ltd.

    collaborator UNKNOWN

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • National Vaccine and Serum Institute, China

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-04
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262010 on ClinicalTrials.gov