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A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

2018年1月9日 更新者：GlaxoSmithKline

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.

One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.

The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.

The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

研究类型

介入性

注册 (实际的)

200

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

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

1个月 至 3个月 (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 with a live twin living in the same household who is also enrolled in this study.
  • Born after a gestation period of ≥32 weeks,
  • Discharged from hospital neonatal care stay,
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parent or guardian of the subjects.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Any clinically significant history of chronic gastrointestinal disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Contact with an immunosuppressed individual.
  • 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 (pharmaceutical product or device).
  • Chronic administration of immunosuppressants since birth.
  • Gastroenteritis within 7 days preceding the first study vaccine administration.
  • Documented HIV-positive subject.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
生物：Rotarix
Two-dose oral vaccination.
安慰剂比较：Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
生物：Rotarix
Two-dose oral vaccination.
生物：Placebo
Two-dose oral administration.

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
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
大体时间：On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.

次要结果测量

结果测量
措施说明
大体时间
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
大体时间：From Day 0 up to Week 13.
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
大体时间：During the entire study period (up to Visit 4, Week 17).
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
大体时间：During the entire study period (up to Visit 4, Week 17).
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
大体时间：At Visit 3 (Week 13).
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
At Visit 3 (Week 13).
Anti-rotavirus IgA Antibody Concentration.
大体时间：At Visit 3 (Week 13).
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
大体时间：Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.

GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.

RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).
Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
大体时间：Within 31 days after any doses.
An AE is 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.
Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
大体时间：Up to Visit 4.

A serious adverse event (SAE) is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Up to Visit 4.

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)

2007年1月23日

初级完成 (实际的)

2008年1月23日

研究完成 (实际的)

2008年2月13日

研究注册日期

首次提交

2006年11月6日

首先提交符合 QC 标准的

2006年11月6日

首次发布 (估计)

2006年11月7日

研究记录更新

最后更新发布 (实际的)

2018年2月6日

上次提交的符合 QC 标准的更新

2018年1月9日

最后验证

2017年11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

  • 106260

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. 知情同意书
    信息标识符：106260
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 数据集规范
    信息标识符：106260
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究协议
    信息标识符：106260
    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：106260
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 统计分析计划
    信息标识符：106260
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 临床研究报告
    信息标识符：106260
    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：106260
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register

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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