EUCTR2009-017282-35-PT进行中（未招募）1 期
A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects - HPV-062 EXT:015
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Written informed consent obtained from the subject prior to enrolment.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •A subject previously enrolled in the study HPV-015 and who fulfils either of the following criteria:
- •-displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding HPV-015 study visit
- •-was pregnant so that no cervical sample could be collected at her concluding HPV-015 study visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject who at the HPV-015 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
- •A subject who at the HPV-015 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her HPV-015 exit colposcopy.
- •A subject for whom the cervical cytology results from the concluding HPV-015 study visit were unavailable for reasons other than pregnancy.
研究者
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不适用
A phase IIIb, open, multi centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final 580299/008 study visit (Visit 10 at Month 48). - HPV-052 EXT 008GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.EUCTR2008-008124-33-FIGlaxoSmithKline Biologicals2,000
进行中（未招募）
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Gynaecological follow-up of a subset of 580299/008 study subjectsGSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.MedDRA version: 15.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862EUCTR2008-008124-33-DEGlaxoSmithKline Biologicals2,000