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Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

NCT06243666 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2188

Last updated 2025-07-31

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Conditions

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.

OTHER

No intervention

No intervention was implemented.

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

  • Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China

    collaborator UNKNOWN

  • Xiamen University

    lead OTHER

Principal Investigators

  • Ting Wu, Ph. D. · Xiamen University

  • Jun Zhang, MSc · Xiamen University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT06243666 on ClinicalTrials.gov