此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

2018年4月27日 更新者：GlaxoSmithKline

Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

415

阶段

  • 第四阶段

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

  • 德国
      • Berlin、德国、12627
        • GSK Investigational Site
      • Berlin、德国、13507
        • GSK Investigational Site
      • Berlin、德国、13355
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ettenheim、Baden-Wuerttemberg、德国、77955
        • GSK Investigational Site
      • Kehl、Baden-Wuerttemberg、德国、77694
        • GSK Investigational Site
      • Oberkirch、Baden-Wuerttemberg、德国、77704
        • GSK Investigational Site
      • Offenburg、Baden-Wuerttemberg、德国、77654
        • GSK Investigational Site
    • Bayern
      • Cham、Bayern、德国、93413
        • GSK Investigational Site
      • Kaufering、Bayern、德国、86916
        • GSK Investigational Site
      • Landshut、Bayern、德国、84032
        • GSK Investigational Site
      • Muenchen、Bayern、德国、80939
        • GSK Investigational Site
      • Olching、Bayern、德国、82140
        • GSK Investigational Site
      • Weilheim、Bayern、德国、82362
        • GSK Investigational Site
    • Hessen
      • Eschwege、Hessen、德国、37269
        • GSK Investigational Site
      • Koenigstein、Hessen、德国、61462
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter、Niedersachsen、德国、38226
        • GSK Investigational Site
      • Wolfenbuettel、Niedersachsen、德国、38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Erkrath、Nordrhein-Westfalen、德国、40699
        • GSK Investigational Site
      • Goch、Nordrhein-Westfalen、德国、47574
        • GSK Investigational Site
      • Guetersloh、Nordrhein-Westfalen、德国、33332
        • GSK Investigational Site
      • Heiligenhaus、Nordrhein-Westfalen、德国、42579
        • GSK Investigational Site
      • Kleve-Materborn、Nordrhein-Westfalen、德国、47533
        • GSK Investigational Site
      • Krefeld、Nordrhein-Westfalen、德国、47798
        • GSK Investigational Site
      • Loehne、Nordrhein-Westfalen、德国、32584
        • GSK Investigational Site
      • Muenster、Nordrhein-Westfalen、德国、48159
        • GSK Investigational Site
      • Willich、Nordrhein-Westfalen、德国、47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Kreuznach、Rheinland-Pfalz、德国、55543
        • GSK Investigational Site
      • Frankenthal、Rheinland-Pfalz、德国、67227
        • GSK Investigational Site
      • Mainz、Rheinland-Pfalz、德国、55131
        • GSK Investigational Site
      • Trier、Rheinland-Pfalz、德国、54294
        • GSK Investigational Site
      • Worms、Rheinland-Pfalz、德国、67547
        • GSK Investigational Site
      • Worms、Rheinland-Pfalz、德国、67549
        • GSK Investigational Site
    • Sachsen
      • Dresden、Sachsen、德国、01307
        • GSK Investigational Site
      • Dresden、Sachsen、德国、01169
        • GSK Investigational Site
    • Schleswig-Holstein
      • Brunsbuettel、Schleswig-Holstein、德国、25541
        • GSK Investigational Site
      • Flensburg、Schleswig-Holstein、德国、24937
        • GSK Investigational Site
      • Flensburg、Schleswig-Holstein、德国、24939
        • GSK Investigational Site
      • Flensburg、Schleswig-Holstein、德国、24943
        • 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

9年 至 13年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
  • Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during study period.
  • 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.
  • Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
  • History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
  • Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.

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：非随机化
  • 介入模型：并行分配
  • 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：BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
生物：Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
实验性的：BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
生物：Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

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 With Any Grade 3 Solicited Local Symptoms
大体时间：During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Days 0-3) follow-up period after booster vaccination

次要结果测量

结果测量
措施说明
大体时间
有任何自发局部症状的受试者人数
大体时间：在加强疫苗接种后的 4 天（第 0-3 天）随访期内
评估征求的局部症状是疼痛、发红和肿胀。 任何 = 症状的发生与强度等级无关。
在加强疫苗接种后的 4 天（第 0-3 天）随访期内
Number of Subjects With Any Solicited General Symptoms
大体时间：During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and Anti-T Antibody Concentrations
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-Polio 1, 2 and 3 Antibody Titers
大体时间：Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody titers were presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
大体时间：One month after booster vaccination (At Month 1)
Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
One month after booster vaccination (At Month 1)
Number of Subjects With Unsolicited Adverse Events (AEs)
大体时间：During the 31-day (Days 0-30) follow-up period after booster vaccination
AEs results are presented for all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
大体时间：During the entire booster period (Month 0 to Month 1)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire booster period (Month 0 to Month 1)

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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)

2008年2月1日

初级完成 (实际的)

2008年7月8日

研究完成 (实际的)

2008年7月8日

研究注册日期

首次提交

2008年3月6日

首先提交符合 QC 标准的

2008年3月6日

首次发布 (估计)

2008年3月13日

研究记录更新

最后更新发布 (实际的)

2018年6月6日

上次提交的符合 QC 标准的更新

2018年4月27日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 110947

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

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

研究数据/文件

  1. 数据集规范
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 临床研究报告
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 知情同意书
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 个人参与者数据集
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 研究协议
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 统计分析计划
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 带注释的病例报告表
    信息标识符：110947
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register

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.

订阅