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| ID | Type | Description | Link |
|---|---|---|---|
| 311-HPV-1003-EXTEND | Other Identifier | Shanghai Zerun Biotech |
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| Name | Class |
|---|---|
| Yuxi Zerun Biotechnology Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV-2 vaccine group | Participants received the bivalent HPV vaccine (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . |
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| Placebo group | Participants received the placebo (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV-16/18 vaccine | Biological | Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 96 months and 120 months after initial vaccination in base study. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection | 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+ | Up to 96 months and 120 months after initial vaccination in base study. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in this long-term follow-up study were originally enrolled in the 311-HPV-1003 study and are drawn from multiple clinical sites across four provinces in China, including Guangxi, Hebei, Henan, and Shanxi. These participants represent a community-based sample of healthy women who received at least one dose of the Bivalent HPV vaccine or Placebo during the original study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingchuan Center for Disease Control and Prevention | Lingchuan | Guangxi | China | |||
| Quanzhou Center for Disease Control and Prevention |
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Cervical Samples:
Cervical exfoliated cells collected at the 96-month and 120-month visits for ThinPrep Cytologic Testing (TCT) and HPV DNA typing.
Biopsy Samples:
Tissue samples collected during colposcopy procedures, if biopsy is deemed necessary.
| Placebo | Biological | Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance. |
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| HPV 16/18 neutralizing antibody GMT and seropositivity rates | At 96 months and 120 months after initial vaccination in base study. |
| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D011230 | Precancerous Conditions |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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