EUCTR2014-000126-38-GB进行中（未招募）1 期
Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following vaccination with serogroup B meningococcal vaccine(4CMenB) - Investigating the immune response to 4CMenB in infants(EUCLIDS)2+1
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
- 187
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
入选标准
- •Healthy infants of two Caucasian parents (self-defined by parent) born between 37 and 42 weeks of gestation aged 8-12 weeks at time of first visit
- •Parent or legal guardian willing and able to comply with the requirements of the protocol and have internet access for the duration of the study.
- •Parent/legal guardian who have given informed consent for their child’s participation in the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Non-Caucasian infants
- •Children of parents who are on the delegation log for this study
- •Parent/ legal guardian under the age of 18
- •History of invasive meningococcal B disease
- •Previous vaccination with meningococcal serogroup B vaccine
- •History of being a household contact with a case of confirmed bacterial meningitis
- •Prior administration of any vaccine or planned administration of any vaccine not specified in the study protocol, with the exception of Hepatitis B vaccine and Influenza vaccines (which can be given 14 days before or after study vaccines), or BCG (which can be administered 28 days before or after study vaccines)
- •Prior or planned receipt of any other investigational vaccine or drug
- •Confirmed or suspected immunodeficiency
- •A family history of congenital or hereditary immunodeficiency, or maternal HIV
- •Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
- •History of allergy to any component of the vaccine
- •Major congenital defects or serious chronic illness
- •History of any neurologic disorders or seizures
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- •Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements (this may include plans to move house and language comprehension).
- •No internet access for the duration of the study.
研究者
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