EUCTR2009-012219-16-DE进行中（未招募）不适用
A phase IV, open-label, non-randomised, multicentre study to assess the immunogenicity and reactogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus, acellular pertussis and inactivated poliovirus vaccine dTpa-IPV (Boostrix Polio) when administered in healthy adults, 10 years after a booster vaccination in study 711866/003 (dTpa-IPV-003). - DTPA-IPV (BOOSTRIX-IPV)-012 BST: 003
适应症
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
- 300
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
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Male or female subjects who have received a dTpa-IPV, dTpa + IPV or Td-IPV vaccine in study NCT01277705.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •–Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal.
- •Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:
- •–practices/has practiced adequate contraception for 30 days prior to vaccination, and
- •–has a negative pregnancy test on the day of vaccination, and
- •–agrees to continue adequate contraception during the entire booster epoch.
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Td-IPV group.
- •History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Occurrence of any of the following adverse event (AE) after a previous administration of a DTP vaccine:
- •–Hypersensitivity reaction to any component of the vaccine,
- •–encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
- •–fever = 40°C within 48 hours of vaccination not due to another identifiable cause,
- •–collapse or shock-like state within 48 hours of vaccination,
- •–convulsions with or without fever, occurring within 3 days of vaccination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Acute disease and/or fever at the time of enrolment.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究者
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