EUCTR2004-004962-33-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 First and the Third Immunization with Chiron Meningococcal C Conjugate Vaccine Menjugate® Administered to Healthy Infants at 2, 3 and 4 Months of Age - N/A
Chiron S.r.l.0 个研究点目标入组 75 人开始时间: 2005年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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 infants aged 8-11 weeks;
- •2.available for the visits scheduled in the study;
- •3.in good health as determined by:
- •-medical history
- •-clinical judgment of the investigator
- •-physical examination check performed by a physician;
- •4.whose parents can give written informed consent for the infant to be enrolled in the study. The infant’s parents must be willing for the infant to receive the full primary immunisation course.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.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 contained within the routine immunisation schedule;
- •3.Unacceptable concurrent illnesses or conditions - infants:
- •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, e.g. Down’s syndrome;
- •c.with any immunodeficiency, including use of systemic corticosteroids;
- •d.who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days;
- •e.born at less than 36 weeks gestation;
- •f.weighing less than 2.5 kg at birth;
- •g.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;
- •h.with a known bleeding diathesis, or any condition associated with a prolonged bleeding time;
- •4. Prohibited prior or concomitant medicationsa.
- •a. Previous immunization with Meningococcal C Conjugate vaccine or any other elements of the routine primary immunisation schedule (excluding BCG given at birth or Hepatitis B given at birth if mother is HBsAg positive);
- •b.Receipt of immunoglobulin;
- •c.Receipt of any blood products;
- •d.Antibiotic or antiviral therapy within the previous 14 days prior to visits including a blood draw;
- •5. Previous participation in this trial, current participation in another trial or participation in another trial within the last thirty days:
- •a.Participation in any other clinical trial either currently or in the previous month;
- •b.Inability to adhere to the protocol, including plans to move from the area;
- •6. Temporary Exclusion Criteria
- •Any infant with axillary temperature of = 38.0°C or any presence of any acute systemic illness on the day of immunisation.
- •With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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