ISRCTN78768849已完成不适用
A single centre randomised clinical trial to assess the antibody response to a 23-valent pneumococcal polysaccharide vaccine administered to adults aged between 50 - 70 years following a 0, 1 or 2 dose priming immunisation with a 7-valent pneumococcal conjugate vaccine
niversity of Oxford (UK)0 个研究点目标入组 348 人开始时间: 2006年7月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 348
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 adults aged 50 - 70 years inclusive
- •2. In good health as determined by:
- •2.1. Medical history
- •2.2. History-directed physical examination
- •2.3. Clinical judgment of the investigator
- •3. Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
- •4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
排除标准
- •1. Have previously received any pneumococcal vaccine
- •2. Have received vaccination with a vaccine containing either CRM197 or Diphtheria toxoid within the past 12 months
- •3. Have a previous ascertained or suspected disease caused C. diphtheriae, or Pneumococcus
- •4. Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
- •5. Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
- •5.1. Receipt of any immunosuppressive therapy
- •5.2. Receipt of immunostimulants
- •5.3. Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy* (*prednisolone or equivalent for more than two consecutive weeks within the past 3 months)
- •6. Have a suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
- •7. Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
- •8. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- •9. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •10. Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure
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