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Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

2019年6月6日 更新者：GlaxoSmithKline

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

研究类型

介入性

注册 (实际的)

137

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Quebec、加拿大、G1S 2L6
        • GSK Investigational Site
    • Alberta
      • Edmonton、Alberta、加拿大、T5A 4L8
        • GSK Investigational Site
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6H 3N1
        • GSK Investigational Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3K 6R8
        • GSK Investigational Site
      • Truro、Nova Scotia、加拿大、B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Waterloo、Ontario、加拿大、N2L 6H6
        • GSK Investigational Site
    • Quebec
      • Sherbrooke、Quebec、加拿大、J1H 1Z1
        • GSK Investigational Site
  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • GSK Investigational Site
      • Golden、Colorado、美国、80401
        • GSK Investigational Site
    • Florida
      • Coral Gables、Florida、美国、33134
        • GSK Investigational Site
      • Miami、Florida、美国、33136
        • GSK Investigational Site
    • Georgia
      • Augusta、Georgia、美国、30912
        • GSK Investigational Site
    • Iowa
      • Iowa City、Iowa、美国、52242
        • GSK Investigational Site
    • Kansas
      • Wichita、Kansas、美国、67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • GSK Investigational Site
      • Louisville、Kentucky、美国、40202
        • GSK Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68131
        • GSK Investigational Site
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • GSK Investigational Site
    • North Carolina
      • New Bern、North Carolina、美国、28562
        • GSK Investigational Site
    • Ohio
      • Cleveland、Ohio、美国、44122
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie、Pennsylvania、美国、15106
        • GSK Investigational Site
      • Erie、Pennsylvania、美国、16508
        • GSK Investigational Site
      • Erie、Pennsylvania、美国、16507
        • GSK Investigational Site
      • Pittsburgh、Pennsylvania、美国、15236
        • GSK Investigational Site
    • Texas
      • Houston、Texas、美国、77030
        • GSK Investigational Site
    • Utah
      • Salt Lake City、Utah、美国、84109
        • GSK Investigational Site
      • Salt Lake City、Utah、美国、84121
        • GSK Investigational Site
    • Washington
      • Wenatchee、Washington、美国、98801
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

26年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
  • Written informed consent obtained from the subject
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrolment will be deferred until the subject is outside of specified window.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:

  • if they test positive for oncogenic HPV infection, but display normal cervical cytology at their concluding HPV-015 study end visit;

  • if they are pregnant so that no cervical sample can be taken at their concluding HPV-015 study end visit;

    • Previous administration of any components of the vaccine.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • Cancer or autoimmune disease under treatment.
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
生物：GSK580299 (Cervarix)
3 剂计划肌内接种疫苗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
大体时间：During the entire study period (from Day 0 up to Month 12)
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
大体时间：During the entire study period (from Day 0 up to Month 12)
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
大体时间：During the entire study period (from Day 0 up to Month 12)
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
大体时间：During the entire study period (from Day 0 up to Month 12)
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
During the entire study period (from Day 0 up to Month 12)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年4月1日

初级完成 (实际的)

2017年11月23日

研究完成 (实际的)

2017年11月23日

研究注册日期

首次提交

2010年8月26日

首先提交符合 QC 标准的

2010年8月26日

首次发布 (估计)

2010年8月27日

研究记录更新

最后更新发布 (实际的)

2019年6月19日

上次提交的符合 QC 标准的更新

2019年6月6日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 113621

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD 共享时间框架

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD 共享访问标准

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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