ISRCTN37262487已完成不适用
Safety and immunogenicity of conjugate vaccine for meningococcal C disease: a randomised study
Bio-Manguinhos/Fiocruz (Brazil)0 个研究点目标入组 60 人开始时间: 2008年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy
- •2. Both sexes
- •3. Aged between 18 and 50 years
- •4. Capable of understanding and signing Free and Informed Consent Form
- •5. Intellectual level which permits filling out records of adverse events at home
- •6. Capable of understanding risks of the experiment
- •7. Willing test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
- •8. Clinical examination without significant abnormalities
- •9. Laboratorial tests within normal range, or only with clinically non-significant alterations
- •10. Pre-vaccinal level of antibodies against tetanus below 5 IU/mL
- •11. Negative pregnancy test
排除标准
- •1. Pregnancy or breastfeeding
- •2. Personal history of meningitis, any kind
- •3. Previous serious adverse event to any vaccination
- •4. Severe adverse event to tetanus toxoids
- •5. Vaccination against tetanus in the last 2 years
- •6. Anti-allergic vaccines 14 days or less before vaccination
- •7. Blood products in the last 12 months
- •8. Any vaccination 30 days or less before vaccination in test
- •9. Chronic use of any medication, except trivial ones
- •10. Previous use of cytotoxic or immunosuppressive therapy
- •11. Asthma which requires hospital care
- •12. Serious angioedema or anaphylaxis
研究者
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