Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
研究概览
简要总结
Primary Objective:
To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.
详细描述
Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 & 6 months of age)
- •Subjects having participated in PNA19
- •Subject's parents having given authorization to use serum collected in PNA19 for future research
- •The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases
- •Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.
排除标准
- •Not applicable.
研究组 & 干预措施
Group A
Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12
干预措施: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines (Biological)
Group B
Toddlers vaccinated with Infanrix hexa® in study A3L12
干预措施: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines (Biological)
结局指标
主要结局
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
时间窗: Day 0
Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL
次要结局
未报告次要终点