EUCTR2008-008195-13-SE进行中（未招募）不适用
An immunogenicity and safety study of combined adsorbed tetanus, low dose diphtheria and acellular pertussis vaccine (Td5ap and Td1aP) given as a school-leaving booster to 14-15-year-old children primed with a five component acellular pertussis vaccine at 3, 5 and 12 months of age, and a booster dose at 5½ years of age. - Tdap Booster study
Swedish Institute for Infectious Disease Control (SMI)0 个研究点开始时间: 2008年12月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Healthy subject of either gender aged 14 to 15 years eligible for their school-leaving booster for diphtheria, tetanus and pertussis.
- •2. A child who received a complete primary vaccination with 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or TD5aP+IPV) as a booster at 5½ years of age.
- •3. Informed consent form signed by the subject and parent(s)/legal representative.
- •4. Subject understand and comply with the study procedures.
- •5. Female must provide an agreement that they either are sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).
- •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. Acute febrile illness and/or axillary temperature =38.0°C at the time of vaccination
- •2. Immunosuppression (e.g. evidence of impaired cell mediated immunity,, receipt of immunoglobulin, immunosuppressant drugs or systemic corticosteroides within the previous 3 months)
- •3. Receipt of a live vaccine within the last 28 days
- •4. Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole-cell or acellular pertussis vaccines).
- •5. Booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
- •6. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis.
- •7. Hypersensitivity to any component of any of the study vaccines
- •8. Current participation in any other clinical trial or participation in any clinical trial in the previous month
- •9. Inability to adhere to the protocol, including plans to move from the area.
- •10. Severe chronic disease
- •11. Family history of congenital or hereditary immunodeficiency
- •12. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- •13. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •14. Pregnant woman (positive pregnancy test), nursing mothers and/or women planning pregnancy during the course of the study
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