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Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women

NCT06776055 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5372

Last updated 2025-01-15

No results posted yet for this study

Summary

This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.

Conditions

  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • CIN - Cervical Intraepithelial Neoplasia
  • Human Papillomavirus Infection

Interventions

BIOLOGICAL

HPV-16/18 vaccine

Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)

BIOLOGICAL

Placebo

Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.

Sponsors & Collaborators

  • Yuxi Zerun Biotechnology Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06776055 on ClinicalTrials.gov