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临床试验/NCT01432340
NCT01432340Unknown不适用

Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
10,000
试验地点
2
主要终点
Laboratory-confirmed influenza infection

研究概览

简要总结

Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed countries. However, little is know about the effectiveness of influenza vaccine in the developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP) under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya, Lwak (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a three-year influenza vaccine effectiveness study using the commercially available southern hemisphere seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and for 2011 and 2012. The study will evaluate the effectiveness of the vaccine in preventing laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing children with influenza vaccine will decrease influenza-associated acute respiratory infections among children and may reduce the number of non-specific acute respiratory infections in vaccinated children and their household contacts.

详细描述

Vaccine will be donated by Sanofi Pasteur in a quantity large enough to vaccinate the eligible population. Vaccine will be made available to infants from 6 months of age through children up to 10 years old. This includes an age group that is at high risk for severe outcomes (<5 years) and an age group (school-age children, 5-10) that is considered most likely to spread the infection.

Ascertainment of Influenza Illness:

Primary Outcome Measure

• Laboratory-confirmed influenza infection

Secondary outcome measures

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6months -10 years
  • Enrolled in the IEIP morbidity study

排除标准

  • Age less than 6 months or greater than or equal to 11 years
  • Not enrolled in the IEIP morbidity study

研究组 & 干预措施

Vaccinated group

Children between 6months- 10years of age who have received the influenza vaccine

干预措施: Seasonal influenza vaccine (Biological)

Unvaccinated group

Eligible children between 6months and 10years who didn't receive the influenza vaccine

干预措施: Seasonal influenza vaccine (Biological)

结局指标

主要结局

Laboratory-confirmed influenza infection

时间窗: June 2010-March 2013 (3 yrs)

Look at the number of vaccinated children who develop laboratory-confirmed influenza infection compared to a matched unvaccinated group of children.

次要结局

  • Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members(June 2011-March 2013 (2 yrs))
  • Medically attended Influenza Like Illness(ILI) and Severe Acute Respiratory Illness (SARI)(June 2011-March 2013 (2 yrs))
  • Community-reported ILI SARI(June 2011- March 2013 (2 yrs))

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Mark Katz

Medical Epidemiologist

Centers for Disease Control and Prevention

研究点 (2)

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