EUCTR2009-013411-36-DK进行中（未招募）不适用
Immunogenicity and safety of a tetanus, diphtheria and mono component acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as a booster vaccination to adults
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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. Healthy female or male adult of = 18 years of age
- •2. Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
- •3. Signed informed consent
- •4. Prepared to grant authorised persons access to medical records
- •5. Likely to comply with instructions
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Congenital or acquired immunodeficiency or progressive neurologic disease
- •2. Uncontrolled epilepsy or progressive encephalopathy
- •3. Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
- •4. Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine (e.g. Td, TdaP, TdaP-IPV, DTaP, DTaP-IPV or DTaP-IPV/PRP-T) within 5 years before inclusion
- •5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine (e.g. Act-HIB®, NeisVac-C®, Prohibit®, Menectra®, Hib-TITER®, Meningitec®, Menjugate® or Prevenar®) within 5 years before inclusion
- •6. Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
- •7. Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
- •8. Vaccinated with a live or inactivated vaccine within 1 month before inclusion
- •9. Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
- •10. Administration of any investigational drug product or vaccine within 1 month before inclusion
- •11. Females if pregnant or breastfeeding or not willing to use contraception during the trial
研究者
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