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.
Study Type
OBSERVATIONAL
Enrollment
5,372
Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)
Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.
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
Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
HPV 16/18 neutralizing antibody GMT and seropositivity rates
Time frame: At 96 months and 120 months after initial vaccination in base study.
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