NCT00197821已完成2 期
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 611
- 主要终点
- Immunogenicity
研究概览
简要总结
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
排除标准
- •Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
- •Current participation in any other clinical trial
- •Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
- •Prior pneumococcal conjugate vaccine (PNC)
- •23 valent pneumococcal vaccine(PPV) in last 5 years
- •Severe general or local reaction to a previous dose of PNC or PPV
- •Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
- •Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
- •Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
- •Deferral of vaccination if acute systemic illness or temperature >38C on day of vaccination
结局指标
主要结局
Immunogenicity
时间窗: Completed by dec 2008
ELISA based asssay for serotype specific pneumococcal responses
次要结局
未报告次要终点
研究者
Dr. Elizabeth Miller
Consultant epidemiologist
Public Health England
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