Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants Aged 2 and 6 Months and Toddlers Aged 4-6 Years Following Administration of GlaxoSmithKline (GSK) Biologicals' IPV-containing Vaccines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Presence of serum anti-PCV-1 antibody.
研究概览
简要总结
This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies [217744/085 and 213503/048] conducted in the United States.
详细描述
Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) 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
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled previously in randomized, open and multicentre studies [217744/085; 213503/048].
- •Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
- •Subjects for whom sufficient residual volume of the pre and post vaccination blood samples is available.
排除标准
- •Not Applicable
结局指标
主要结局
Presence of serum anti-PCV-1 antibody.
时间窗: At Day 0 and post vaccination time points (up to 1 month after vaccination).
次要结局
未报告次要终点