Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- To provide information concerning the safety and immunogenicity after administration of TetraMenT
研究概览
简要总结
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
- A single dose of each formulation of TetraMen-T vaccine
- A single dose of NeisVac-C® vaccine.
详细描述
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 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
研究组 & 干预措施
Group 5
干预措施: Meningococcal Polysaccharide Tetanus Protein Conjugate (Biological)
Group 6
干预措施: Meningococcal polysaccharide group C conjugated (Dietary Supplement)
Group 1
干预措施: Meningococcal Polysaccharide Tetanus Protein Conjugate (Biological)
Group 2
干预措施: Meningococcal Polysaccharide Tetanus Protein Conjugate (Biological)
Group 3
干预措施: Meningococcal Polysaccharide Tetanus Protein Conjugate (Biological)
Group 4
干预措施: Meningococcal Polysaccharide Tetanus Protein Conjugate (Biological)
结局指标
主要结局
To provide information concerning the safety and immunogenicity after administration of TetraMenT
时间窗: 30 days after each injection
次要结局
未报告次要终点