EUCTR2015-005589-43-Outside-EU/EEA进行中（未招募）不适用
Safety and immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (ADACEL™) Vaccine compared to Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine (QUADRACEL™) as fifth dose in children 4-6 years of age
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
- 600
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
- •A subject must meet all the following criteria in order to be included in the study:
- •1. Age > 4 years and < 7 years.
- •2. Signed and dated IRB approved informed consent form obtained prior to the first study intervention.
- •3. Judged to be in good health on the basis of reported medical history and examination.
- •4. Plans to remain in the study area for the length of the trial.
- •5. Parent or legal guardian can read and write English/French and can understand the informed consent documents and the study instructions and is mentally competent to give consent.
- •6. Parent or legal guardian has access to a telephone.
- •7. Has documentation of complete primary series and fourth dose, consisting of exactly four previous administrations of the pentavalent HCPDT-mIPV/PRP-T vaccine (PENTACEL™).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •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
- •A subject who meets any of the following criteria will not be eligible for inclusion in the study:
- •1. Known or suspected primary or acquired disease of the immune system, including autoimmune diseases such as rheumatoid arthritis or inflammatory bowel disease.
- •2. Any unstable, significant underlying chronic disease, including, but not limited to, malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder.
- •3. Receipt of immunosuppressive therapy for chronic immune disorders or malignancy.
- •4. Daily use of oral or inhaled corticosteroids for any medical conditions: e.g. daily systemic prednisone > 1 mg/kg (However, topical corticosteroids or inhaled corticosteroids that are taken on an occasional basis, or for < 7 days, as long as there are not two courses within the previous two weeks prior to vaccination, are not an exclusion criterion.).
- •5. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
- •6. Seizures disorder due to epilepsy or any other known neurologic impairment, whether active or medically controlled.
- •7. Any other condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- •8. Receipt of any other vaccine or of allergy shots within the past 30 days, or planning to receive another vaccine or allergy shots before completion of the study.
- •9. Receipt of an investigational product as part of another clinical trial within the past 30 days, or planning to receive another investigational product before completion of the study.
- •10. Receipt of blood products or immunoglobulin within the past 3 months.
- •11. Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months.
- •12. Known or suspected allergy to any of the vaccines or vaccine components intended for use in the study.
- •13. Previous severe reactions to any of the vaccines used in this study, including anaphylaxis immediately following the vaccine, seizure within 3 days of receiving the vaccine, or encephalopathy within 7 days of receiving the vaccine.
- •Temporary Contraindications for All Immunizations (the dose will be deferred)
- •A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:
- •1. Oral temperature > 38.0 degrees C
- •2. Known or suspected acute infectious respiratory illness, with one or more of the following active symptoms and signs: rhinorrhea, new cough, pharyngitis, and respiratory problems (e.g., wheezing, shortness of breath).
研究者
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