PACTR202102660004195尚未招募2 期
nderstanding the magnitude and kinetics of the serological responses to killed Oral Cholera Vaccine (OCV) when given 2 to 3 years after an initial receipt of OCV in Cameroon
Meilleur Acces aux Soins de Sante0 个研究点目标入组 360 人开始时间: 2021年1月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
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
- 年龄范围
- 1 Month(s) 至 23 Month(s)(—)
- 性别
- All
入选标准
- •1.Age =1 year at the time of the 2017 OCV campaign, stratified into different age groups
- •2.Living in the Mogode Health Area where the OCV campaign was carried out
- •3.Good health condition, without clinically significant medical history (by participant or guardian, in case of minor)
- •4.Not pregnant for female subjects (confirmed by a urine pregnancy test)
- •5.Available to participate for the study duration, including all planned follow-up visits for up to 42 days from the time of screening.
- •6.Signed informed consent
排除标准
- •1.Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of TB or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function , such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
- •2.Receipt of an investigational product (within 30 days before vaccination).
- •3.History of diarrhoea in 7 days prior to first dose of vaccine (defined as =3 unformed loose stools in 24 hours).
- •4.History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
- •5.Current use of laxatives, antacids, or other agents to lower stomach acidity?
- •6.Planning to become pregnant in the next 2 months
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