EUCTR2015-005844-32-Outside-EU/EEA进行中（未招募）不适用
One-, Three-, Five- and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adolescents 11–14 Years of Age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participation in original Study Td9805 and the receipt of Tdap.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy or planning a pregnancy during the study period.
- •2. Known or suspected primary disease of the immune system (conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5).
- •3. Malignancy or receiving immunosuppressive therapy (e.g. daily systemic prednisone 1 mg/kg would be excluded. Participants who were taking topical and inhaled steroids could be included in the study as could participants on a short course” of oral steroids, 5-7 days, as long as there were not two courses within the previous two week period.)
- •4. Receipt of any pertussis, diphtheria or tetanus containing vaccines within the previous 5 years.
- •5. Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
- •6. Known impairment of neurologic function or seizure disorder of any etiology.
- •7. Personal history of physician diagnosed or laboratory confirmed pertussis disease within the previous 2 years.
- •8. Receipt of blood products or immunoglobulin within the previous 3 months.
- •9. Known or suspected allergy to any of the vaccines intended for use in the study.
- •10. Receipt of any vaccine within 2 weeks of receiving a study vaccine.
- •11. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
研究者
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