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临床试验/NCT00125047
NCT00125047已完成4 期

Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

International Vaccine Institute1 个研究点 分布在 1 个国家目标入组 27,231 人开始时间: 2001年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
27,231
试验地点
1
主要终点
Total protection against S. typhi

研究概览

简要总结

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

详细描述

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence; is given as a single dose; lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.

Secondary objectives of this trial are:

  • To monitor the adverse events following a routine Vi mass vaccination campaign;
  • To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
  • To study typhoid fever risk factors in the population.

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Registered in the project census
  • Age: 2-16 years

排除标准

  • Fever >37.5 degrees Celsius, axillary
  • Pregnancy
  • Lactating

结局指标

主要结局

Total protection against S. typhi

时间窗: 2 years from zero time

次要结局

  • Indirect protection against s. typhi(two years from zero time)
  • Overall protection against s. typhi(2 years from zero time)
  • Adverse event(s) following immunization(30 days from vaccination)

研究者

申办方类型
Other

研究点 (1)

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