EUCTR2012-002575-34-Outside-EU/EEA进行中（未招募）1 期
A phase IIIb, open, multi-center study to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals’ MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals’ Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 and 4 years after MenACWY-TT booster vaccination. - MENACWY-TT-106 EXT:HIB-MENC-TT-016 Y6,8,10
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
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’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
- •Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- •Having completed the vaccination in study HIB-MENC-TT-016 (106445) as per protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 156
- •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 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 vaccine dose.
- •Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
- •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 vaccine/product (pharmaceutical product or device).
- •Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the HIB-MENC-TT-016 study.
- •History of meningococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
- •Acute disease and/or fever at the time of enrollment.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e., between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3 and Visit 4.
- •The following criteria should be checked for the long-term persistence phase at two and four years after booster vaccination (Visit 3 and Visit 4):
- •Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in HIB-MENC-TT-016 and the booster vaccination in this particular study.
- •History of meningococcal disease
研究者
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