NCT01277705已完成3 期
Assess Immunogenicity, Reactogenicity of GSK Biologicals'-dTpa-IPV Vaccine Versus dTpa & IPV Vaccines Administered Separately & Compared With Aventis Pasteur MSD's Td-IPV Vaccine When Administered to Healthy Adolescents & Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 806
- 主要终点
- Immunogenicity with respect to components of the study vaccines
研究概览
简要总结
This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination.
- •Written informed consent obtained.
- •Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge.
- •Female subjects must not be pregnant or lactating.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
- •History of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years.
- •French subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
- •German subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup.
- •German subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
- •Administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination.
- •Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition,
- •History of seizures or progressive neurological disease.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- •The following adverse experiences associated with diphtheria-tetanus-pertussis vaccination constitute absolute contraindications to further administration of diphtheria-tetanus-pertussis vaccine; if any of these adverse experiences occurred following previous vaccinations, the subject should not be included:
- •Absolute contraindications:
- •Hypersensitivity reaction due to the vaccine.
- •Encephalopathy
- •Precautions:
- •Fever >= 40.0°C within 48 hours of vaccination not due to another identifiable cause.
- •Collapse or shock-like state within 48 hours of vaccination.
- •Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
- •Seizures with or without fever occurring within 3 days of vaccination.
结局指标
主要结局
Immunogenicity with respect to components of the study vaccines
时间窗: One month after vaccination (Month 1)
次要结局
- Immunogenicity with respect to components of the study vaccines(One month after vaccination (Month 1))
- Immunogenicity with respect to some component of the study vaccines(At Day 10 after vaccination)
- Occurrence of serious adverse events(Throughout the entire study (from Day 0 to Day 30))
- Occurrence of solicited local and general symptoms(within 15 (Day 0-14) days after vaccination)
- Occurrence of unsolicited symptoms(within 30 days (Day 0-29) after vaccination)
研究者
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