NCT00307567已完成2 期
A Phase II, Multicentre Booster Study to Evaluate Booster Vaccination With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following the Administration of a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 11PN-PD-DIT-002 (103488)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 689
- 试验地点
- 52
- 主要终点
- 1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
研究概览
简要总结
Booster and immune memory study
详细描述
Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
次要结局
- Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
- S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
- Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster
- Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
- Ab concentrations to protein D & seropositivity (S+) status
- Occurrence of: solicited local*,general *symptoms within 4 d
研究者
研究点 (52)
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