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A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

NCT04083196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-24

No results posted yet for this study

Summary

A total of 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45 years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients. 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)

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

BIOLOGICAL

Placebo

Placebo

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
9 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-07
Primary Completion
2021-10-13
Completion
2021-10-13

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 NCT04083196 on ClinicalTrials.gov