Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
2015年4月2日 更新者：GlaxoSmithKline
Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)
This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo).
Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
研究概览
详细说明
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
研究类型
观察性的
注册 (实际的)
1
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 2个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.
描述
Inclusion Criteria:
Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
- Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
- Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.
- Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.
Exclusion Criteria:
- Not Applicable
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
HRV Group
Subjects who had received 2 doses of HRV vaccine in previous studies.
|
Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study.
Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
|
|
Placebo Group
Subjects who had received 2 doses of placebo in previous studies.
|
Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study.
Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Seropositivity rates for anti-PCV-1 antibodies.
大体时间：At 1-2 months post dose 2 of HRV vaccine or placebo.
|
At 1-2 months post dose 2 of HRV vaccine or placebo.
|
|
Seroconversion rates for anti-PCV-1 antibodies.
大体时间：At 1-2 months post dose 2 of HRV vaccine or placebo.
|
At 1-2 months post dose 2 of HRV vaccine or placebo.
|
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。
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。
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
2014年2月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年5月15日
首先提交符合 QC 标准的
2014年5月29日
首次发布 (估计)
2014年6月3日
研究记录更新
最后更新发布 (估计)
2015年4月6日
上次提交的符合 QC 标准的更新
2015年4月2日
最后验证
2015年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 114793
- 444563/005 (Rota-005)
- 444563/023 (Rota-023)
- 444563/028 (Rota-028)
- 444563/029 (Rota-029)
- 102247 (Rota-036)
- 106481 (Rota-054)
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.