NCT02153333已完成不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Seropositivity rates for anti-PCV-1 antibodies.
研究概览
简要总结
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.
详细描述
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not Applicable
结局指标
主要结局
Seropositivity rates for anti-PCV-1 antibodies.
时间窗: At 1-2 months post dose 2 of HRV vaccine or placebo.
Seroconversion rates for anti-PCV-1 antibodies.
时间窗: At 1-2 months post dose 2 of HRV vaccine or placebo.
次要结局
未报告次要终点
研究者
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