NCT04481243已完成4 期
Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Immunoglobulin G (IgG) Antibodies
研究概览
简要总结
The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 3-18 years old.
- •Clinical diagnosis of Type 1 diabetes.
排除标准
- •Newly diagnosed with Type 1 diabetes with in the past month of study date.
- •Contraindications to receiving 23 valent pneumococcal vaccines.
- •Other conditions associated with compromised immunity and vaccine response.
- •Primary or Secondary Immune deficiency.
- •Previous receipt of PPSV-23 vaccination.
结局指标
主要结局
Immunoglobulin G (IgG) Antibodies
时间窗: 6 months post vaccination
Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL
次要结局
未报告次要终点
研究者
研究点 (2)
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