NCT00524732已完成不适用
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,156
- 主要终点
- To provide safety information on ADACEL® vaccine given at different time intervals.
研究概览
简要总结
To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 7 years and < 20 years.
- •Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
- •Judged to be in good health on the basis of reported medical history.
- •Available for planned length of the study.
- •Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.
- •A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
- •A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
排除标准
- •Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
- •Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
- •Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
- •Receipt of TD/Td within the preceding 12 months.
- •Known or suspected to be pregnant.
- •A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
- •A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
结局指标
主要结局
To provide safety information on ADACEL® vaccine given at different time intervals.
时间窗: Up to 114 months post-vaccination
次要结局
未报告次要终点
研究者
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