EUCTR2013-003768-30-Outside-EU/EEA进行中（未招募）不适用
A phase IV, single-blind, randomized, multicenter study to assess the immunogenicity and safety of GSK Biologicals’ dTpa vaccine (Boostrix™) using a new syringe presentation in healthy adolescents aged 10–15 years. - DTPA (BOOSTRIX)-045
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
- 671
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
- •Subject’s parent(s)/Legally Acceptable Representative(s) [LAR(s)] and subjects who the investigator believes can and are willing to comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •A male or female between 10 and 15 years of age (from and including the 10th birthday up to but excluding the 16th birthday) at the time of booster vaccination.
- •Prior to protocol amendment 2, subjects who have previously received 5 doses of DTP (w/a) as part of primary and booster vaccination, in line with local recommendations.
- •After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
- •Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
- •Written informed consent to be obtained before study entry from the parent(s)/LAR(s) of the subject.
- •Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s), if required by local regulations.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •-Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •-has a negative pregnancy test on the day of vaccination; and
- •-if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 671
- •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
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 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 in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone < 20 mg/day or equivalent, inhaled and topical steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period = 7 days after the study vaccine dose.
- •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).
- •A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
- •A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months .
- •Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine :
- •-known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,
- •-encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
- •-transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Any confirmed or suspected immunosuppressive or immunodeficient 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 (including latex).
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine 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, or = 38.0°C on rectal setting. The preferred route for recording tempera-ture in this study will be oral or axillary.
- •-Subjects with a minor illness (such as mild diarrhea, 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, if applicable.
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