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Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

NCT04782895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2023-06-15

No results posted yet for this study

Summary

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Conditions

Interventions

BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Three doses administered intramuscularly at 0, 45 day and 6 month.

BIOLOGICAL

Gardasil®9

Three doses administered intramuscularly at 0, 45 day and 6 month.

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

  • Feng-cai Zhu, master · Jiangsu Provincial Centre for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-14
Primary Completion
2022-05-30
Completion
2022-07-25

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 NCT04782895 on ClinicalTrials.gov