EUCTR2007-003477-94-DE进行中（未招募）不适用
A phase IV, open, non-randomised, multicentre study to assess the reactogenicity and immunogenicity 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 subjects aged 9-13 years, 5 years after previous booster vaccination with dTpa-IPV in the study 711866/001 (dTpa-IPV-001). - DTPA-IPV (Boostrix-IPV): 008 Ext 001 Y5
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
- •Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001 (dTpa-IPV-001).
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Females of childbearing potential (i.e., who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
- •Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •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 immunosuppressant or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during 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).
- •Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001 (dTpa-IPV-001).
- •History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine:
- •hypersensitivity reaction to any component of the vaccine,
- •encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
- •fever >=40°C (axillary temperature/oral 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,
- •Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine
- •convulsions with or without fever, occurring within 3 days of vaccination.
- •Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C / Axillary temperature < 37.5°C / Tympanic temperature < 37.5°C/ Rectal temperature <38°C.
- •Pregnant or lactating female.
研究者
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