ACTRN12616001230448已完成4 期
Meningococcal disease at Hajj: Vaccine effects on short to medium-term meningococcal nasopharyngeal carriage: comparison of conjugate and polysaccharide quadrivalent ACWY vaccine
ational Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead0 个研究点目标入组 1,146 人开始时间: 2016年9月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •i)Any pilgrim planning to attend Hajj pilgrimage from the selected countries (Australia, Qatar and Saudi Arabia).
- •ii)Aged 18 years or older.
- •iii)Be able to provide informed consent.
排除标准
- •i)Persons who received a MenACWY-C vaccine anytime in the past or a MenACWY-PS in the last three years will be excluded
- •ii)Persons on long-term steroids or other immune suppressants or immunodeficiency conditions will be excluded.
- •iii)Persons with previous history of invasive meningococcal disease will be excluded.
- •iv)Individuals with a history of systemic antibiotic use during the previous 7 days will be temporarily excluded but could be included after a lapse of 7 days since the last day of antibiotic administration. Individuals who give a history of using antibiotics during Hajj (following recruitment) will be retained in trial. A delayed swab, a week after completing the antibiotic course, will be attempted, but if that is not practical, they will be excluded them from the ‘per-protocol’ analysis. Individuals who received a conjugate monovalent meningococcal vaccine (MenC or MenA) in the past can be included into the study, but will be excluded for MenC- or MenA-specific analyses, but will be included for analyses with respect to the other serogroups.
研究者
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