EUCTR2005-003765-17-DE进行中（未招募）1 期
Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses Of BIKEN Acellular Pertussis Vaccine in Combination with Diphtheria and Tetanus Toxoids (Tripedia®) Or Who Have Received Primary Vaccination with 3 Doses of Whole-Cell Pertussis Vaccine, Plus At Least 1 Pertussis Booster Vaccination
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Eligible to receive REPEVAX or COVAXiS vaccine, in accord with German recommendations for a booster dose of acellular pertussis vaccine at 9-17 years of age.
- •2. Signed and dated informed consent or assent form (as applicable) that is obtained prior to the first study intervention.
- •3. Judged to be in good health on the basis of reported medical history and history-directed physical examination.
- •4. Plans to remain in the study area for the length of the trial.
- •5. The participant and a parent or legal guardian can read, write, and understand the documents and all are mentally competent to give assent and consent.
- •6. If female, not known or suspected to be pregnant at the time of enrollment into the study and is not planning pregnancy during participation in this trial.
- •7.Either prior participation in study 371-03/01 (Group 1) or a documented history of 3 doses of tetanus, diphtheria and whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life (Group 2).
- •8. Has access to a telephone.
- •9. Oral temperature < 38.0oC.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •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 [eg, rheumatoid arthritis or inflammatory bowel disease] will not be excluded unless they meet exclusion criterion 3 or 5).
- •3. Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (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. Receipt of any pertussis, diphtheria or tetanus-containing vaccines within the past 3 years.
- •5. Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
- •6. Known impairment of neurologic function or currently active seizure disorder or currently requiring 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 intended for use in the study.
- •10. Daily use of non-steroidal anti-inflammatory drugs.
- •11. Receipt of any vaccine or investigational product within the 30 days prior to enrollment, or planning to receive another vaccine within 28 days after receiving study vaccine.
- •12. Chemical dependency (eg, alcoholism or intravenous drug use but not including nicotine or caffeine), based on investigator judgment.
- •13. 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 (eg. wheezing, shortness of breath).
- •14. 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.
- •15. History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis vaccine.
- •16. Planned participation in another interventional clinical trial during the present trial period (participation in a related study to evaluate immune responses to this study’s vaccination is permitted).
- •17.Thrombocytopenia or bleeding disorder that would pose a contraindication to an IM vaccination.
研究者
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