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Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

NCT03935204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2021-04-08

No results posted yet for this study

Summary

This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Conditions

Interventions

BIOLOGICAL

HPV Vaccine,270μg/1.0ml

HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

BIOLOGICAL

Placebo

Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Xiamen University

    lead OTHER

Principal Investigators

  • Jun Zhang, Master · Xiamen University

  • Yue-Mei Hu, Bachelor · Jiangsu Provincial Centre for Disease Control and Prevention

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
2019-05-13
Primary Completion
2019-10-18
Completion
2021-04-01

Countries

  • China

Study Locations

More Related Trials

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 NCT03935204 on ClinicalTrials.gov