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Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)

NCT04436133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-05-06

No results posted yet for this study

Summary

A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.

Conditions

Interventions

BIOLOGICAL

Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)

Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle

BIOLOGICAL

9-valent HPV vaccine（Gardasil 9）

Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle

Sponsors & Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Simoon Record Pharma Information Consulting Co., Ltd.

    collaborator INDUSTRY

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Beijing Kantorico Statistical Technology Co., Ltd.

    collaborator UNKNOWN

  • 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
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2022-03-01
Completion
2022-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04436133 on ClinicalTrials.gov