NCT00333450已完成3 期
Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 30
- 主要终点
- Antibody concentrations against pneumococcal serotypes 1 month post-booster
研究概览
简要总结
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
详细描述
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
排除标准
- •children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
- •children having received any additional pneumococcal vaccine than in the primary study;
- •children with any disease that affect the immune system and history of seizures and/or allergic disease.
结局指标
主要结局
Antibody concentrations against pneumococcal serotypes 1 month post-booster
次要结局
- Immunogenicity pre and post-booster and safety (follow up of SAEs)
研究者
研究点 (30)
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