Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Charlottetown、加拿大、C1A 7N8
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Nova Scotia
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Halifax、Nova Scotia、加拿大、NS B3K 6R8
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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1
18 to 30 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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2
30 to 42 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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3
42 to 54 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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4
54 to 66 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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5
66 to 78 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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6
78 to 90 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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7
90 to 102 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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8
102 to 114 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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9
Control - over 114 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To provide safety information on ADACEL® vaccine given at different time intervals.
大体时间:Up to 114 months post-vaccination
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Up to 114 months post-vaccination
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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