临床试验/NCT01579825

NCT01579825已完成不适用

Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial

Johns Hopkins Bloomberg School of Public Health1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2012年4月最近更新: 2013年4月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Johns Hopkins Bloomberg School of Public Health
入组人数: 300
试验地点: 1
主要终点: Serologic response

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hypothesis:

The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

详细描述

The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 4 Weeks 至 8 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•infants who are 4-8 weeks old
•residents of study area

排除标准

•received a blood transfusion or any other blood product (such as immune globulin)
•likely to move out of study area within the next four months
•currently enrolled or planning to enroll in another study
•major congenital malformations
•neurologic disorders
•immunodeficiency

结局指标

主要结局

Serologic response

时间窗: 4 weeks after last dose of OPV

Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.

次要结局

未报告次要终点

研究者

发起方

Johns Hopkins Bloomberg School of Public Health

申办方类型

Other

责任方

Sponsor

研究点 (1)

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