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

NCT04537156 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9327

Last updated 2025-11-21

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Nonavalent HPV vaccine

Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

BIOLOGICAL

Bivalent HPV vaccine

Bivalent HPV vaccine (60μg/0.5ml) 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

  • Hong-xing Pan, master · Jiangsu Provincial Centre for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-05
Primary Completion
2027-12-31
Completion
2027-12-31

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 NCT04537156 on ClinicalTrials.gov