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An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old

NCT05056402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1382

Last updated 2025-07-22

No results posted yet for this study

Summary

This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.

Conditions

Interventions

BIOLOGICAL

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

Three doses administered intramuscularly at 0, 1 and 6 month.

BIOLOGICAL

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

Two doses administered intramuscularly at 0 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

  • Xue-cheng Liu, master · Sichuan Provincial Centre for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-19
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT05056402 on ClinicalTrials.gov