EUCTR2006-000732-28-GB进行中（未招募）1 期
A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the C saccharide component of Chiron’s Meningococcal C Conjugate Vaccine (Menjugate®) Administered to Healthy Children at least 12 Months of Age After Priming with Menjugate® at 2, 3 and 4 Months of Age.
Chiron S.r.l.0 个研究点目标入组 0 人开始时间: 2006年2月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. healthy children aged 12-13 months (inclusive) who took part in the previous study to establish the kinetics of the B cell response to MenC vaccine at 2, 3 and 4 months (study M14P5, Eudract number 2004-004962-33)
- •2. available for the visits scheduled in the study;
- •3. in good health as determined by:
- •- medical history
- •- clinical judgment of the investigator
- •- pre-vaccination check performed by a physician if indicated by medical history
- •4. whose parents can give written informed consent for the child to be enrolled in the study.
- •Informed consent must be obtained for all subjects before enrolment into the study.
- •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
- •1. Children whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study
- •2. Known hypersensitivity to any vaccines or constituents
- •3. Unacceptable concurrent illnesses or conditions - children
- •a. with a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- •b. with a genetic anomaly;
- •c. with any immunodeficiency, including use of systemic corticosteroids
- •d. with previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
- •e. with a known bleeding diathesis, or any condition associated with a prolonged bleeding time;
- •4. Prohibited prior or concomitant medications
- •a. Any immunizations, with the exception of those received in the initial phase of the study, BCG, hepatitis B or Hib;
- •b. Receipt of immunoglobulin;
- •c. Receipt of any blood products;
- •5. Participation in any other clinical trial either currently or in the previous month;
- •6. Inability to adhere to the protocol, including plans to move from the area;
- •With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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