EUCTR2009-016012-21-BE进行中（未招募）1 期
A phase IV, open, non-randomized, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine dTpa (Boostrix™) when administered in healthy adult subjects, after previous booster vaccination with dTpa in study 263855/029 (dTpa-029). - DTPA (BOOSTRIX)-041 BST 029
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 647
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
- •All subjects must satisfy ALL the following criteria at study entry:
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •Male or female subjects who have received dTpa-0.5, dTpa-0.3 or dTpa-0.133 vaccine in the study 263855/029 (dTpa-029).
- •Written informed consent obtained from the subject.
- •Additional criteria to be checked before the booster vaccination.
- •Healthy subjects as established by medical history and clinical examination.
- •Female subjects of non-childbearing potential may receive the booster vaccine.
- •?Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal.
- •Female subjects of childbearing potential may 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Exclusion criteria to be checked at study entry:
- •Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029 (dTpa-029).
- •History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Occurrence of any of the following adverse event 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 greater than or equal to 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause,
- •?collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
- •?convulsions with or without fever, occurring within three days of vaccination.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Additional exclusion criteria to be checked for subjects before the booster vaccination administration:
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, prednisone <20 mg/day, or equivalent, inhaled and topical steroids are allowed.
- •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 (pharmaceutical product or device).
- •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.
- •?Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting.
- •?Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
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