EUCTR2016-000645-31-Outside-EU/EEA进行中（未招募）1 期
A phase II, partially double-blind, randomised, controlled, single-centre study to assess the immunogenicity and reactogenicity of three different formulations of GSK Biologicals’ DTPw-HBV-IPV/Hib candidate vaccine compared to the Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to poliovirus vaccine-primed healthy toddlers aged 12-24 months. - DTPW-HBV-IPV=HIB-003
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
- 312
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
- •A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
- •Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR)(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 312
- •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 immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/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 (up to Visit 2).
- •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).
- •History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Hib diseases.
- •Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae dis-eases.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodefi-ciency.
- •Major congenital defects or serious chronic illness.
- •History of neurologic disorders or seizures.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including neomycin and polymyxin).
- •Administration of immunoglobulins 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.
- •Child in care.
- •Occurrence of any of the following adverse event after a previous administration of a DTP vaccine:
- •-encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
- •-fever >= 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 3 days of vaccination.
- •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.
- •-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
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