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The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

NCT05045755 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1339

Last updated 2023-01-26

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Conditions

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection

Interventions

BIOLOGICAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Jun Zhang

    lead OTHER

Principal Investigators

  • Ting Wu, Ph. D. · Xiamen University

Eligibility

Min Age
26 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2023-08-10
Completion
2024-01-31

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 NCT05045755 on ClinicalTrials.gov