EUCTR2014-000052-29-DK进行中（未招募）不适用
Safety and immunogenicity of 3 adjuvated reduced dose inactivated poliovirus vaccines (IPV-Al SSI) and non-adjuvated full dose IPV SSI, given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12 months and 5 years of age
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. Adolescents from = 10 to = 15 years of age at inclusion
- •2. Healthy assessed from medical history and oral temperature at inclusion
- •3.Vaccinated in Denmark according to the current vaccination program of 3 IPV doses in infancy and one IPV dose at pre-school age (i.e. born = 1 July 1999)
- •4. Signed informed consent from adolescent's parent(s)/legal guardian(s) and from 15 years of age also from the adolescent
- •5. Grant of authorised person's access to adolescent's medical records from adolescent's parent(s)/legal guardian(s)
- •6. Is willing and likely to comply with trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 240
- •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. Vaccinated with IPV = 5 years prior to inclusion
- •2. Vaccinated with OPV any time prior to inclusion
- •3. Travelled in wild polio virus endemic region (e.g. Pakistan, Nigeria or Afghanistan) = 5 years prior to inclusion
- •4. History of serious adverse reaction(s) after any previous vaccination
- •5. Known or suspected allergy to active or inactive vaccine constituents
- •6. Vaccinated with a live vaccine (e.g. measles, mumps, rubella, varicella, yellow fever or typhoid) = 1 month prior to inclusion or during the trial. Subjects vaccinated with inactivated vaccines (e.g. tetanus, diphtheria, human papillomavirus, hepatitis A or B) are eligible for inclusion
- •7. Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma)
- •8. Severe uncontrolled disease (e.g. diabetes, asthma, epilepsy, heart or Crohn's disease). Patients in controlled medical treatment may be included, as assessed by the investigator
- •9. In treatment with systemic corticosteroids given p.o., i.v., i.m. = 1 month prior to inclusion or during the trial. Subjects administered corticosteroid topically or by asthma inhalators are eligible for inclusion
- •10. In treatment with immune modulating products = 3 months prior to inclusion or during the trial, e.g. blood products, immunoglobulins, cytostatics (e.g. methotrexate), TNF-antagonists (e.g. etanercerpt, infliximab, adalimumab, golimumab, certolizumab), or immunosuppressants (e.g. azathioprine or ciclosporin)
- •11. In treatment with any investigational medicinal product = 3 months prior to inclusion or during the trial
- •12. A positive pregnancy test result at inclusion (for females who have had their first period) and/or objection to use contraception (for females who are sexually active)
- •13. Is unsuitable for participation in the trial or is not likely to comply with instructions as assessed by the investigator
研究者
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