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NCT06776055

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

Sponsor: Shanghai Zerun Biotechnology Co.,Ltd

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Protective Efficacy and Immunogenic Persistence of the Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) Administered to Healthy Females Aged 18-30 During the 311-HPV-1003 Study

Key Details

Gender

FEMALE

Age Range

18 Years - 30 Years

Study Type

OBSERVATIONAL

Enrollment

5372

Start Date

2023-03-27

Completion Date

2026-06

Last Updated

2025-01-15

Healthy Volunteers

Yes

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.

Locations (9)

Lingchuan Center for Disease Control and Prevention

Lingchuan, Guangxi, China

Quanzhou Center for Disease Control and Prevention

Quanzhou, Guangxi, China

Xing'an Center for Disease Control and Prevention

Xing’an, Guangxi, China

Daming Center for Disease Control and Prevention

Daming, Hebei, China

Dingxing Center for Disease Control and Prevention

Dingxing, Hebei, China

Zhengding Center for Disease Control and Prevention

Zhengding, Hebei, China

Puyang Center for Disease Control and Prevention

Puyang, Henan, China

Wenxian Center for Disease Control and Prevention

Wenquan, Henan, China

Xiangfen County People's Hospital

Xincheng, Shanxi, China