EUCTR2015-005845-30-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 Adults and Adolescents (11-64 years)
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
- 189
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
- •At the sites participating in each of the Long term follow-ups, all subjects in the original study who received a vaccination and provided blood samples were asked to provide a follow-up sample. For the 10-year follow-up, only Tdap subjects were to be included.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 145
- •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 nursing a child.
- •2. Known or suspected primary or acquired 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 5].
- •3. Malignancy, allergy shots or is receiving immunosuppressive therapy (e.g., daily systemic prednisone = 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as would participants on a short course” of oral steroids, =7 days, as long as there are not two courses within the previous two weeks prior to vaccination).
- •4. Prior receipt of any pertussis, diphtheria or tetanus containing vaccines within the past 5 years.
- •5. Any unstable significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
- •6. Known impairment of neurologic function or currently active seizure disorder or currently required medication for seizures.
- •7. Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years.
- •8. Receipt of blood products or immunoglobulin within the previous 3 months.
- •9. Known or suspected allergy to any of the vaccines or vaccine components for tetanus, diphtheria and pertussis intended for use in the study.
- •10. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
- •11. Receipt of any vaccine within 30 days of receiving study vaccine, or is planning to receive another vaccine before the 2nd visit.
- •12. Has a known chemical dependency (e.g., alcoholism or intravenous drug use but not including nicotine or caffeine) based on investigator judgment.
- •13. Has received an investigational product as part of another clinical trial within 30 days prior to study enrollment and can not be enrolled in another clinical trial.
- •14. Has a known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis, respiratory problems (e.g. wheezing, shortness of breath).
- •15. Has any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- •16. Previous reactions to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving the vaccine.
- •Relative Contraindications for All Immunizations (the dose will be deferred) for febrile illness with
- •temperature = 38.0oC (100.4oF) oral within previous 72 hours of vaccination defer the
- •immunization for a minimum of 48 hours from the scheduled immunization.
研究者
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