Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.
研究概览
简要总结
The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations.
Primary Objective :
- To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.
Secondary Objectives :
- To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.
- To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age.
- To describe the safety after the booster dose of the study vaccine.
详细描述
All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.
Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（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
To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.
时间窗: 30 days post-vaccination
次要结局
- To provide information concerning the safety after booster administration of TETRAXIM™.(30 days post-vaccination and entire study period)