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Seasonal Influenza Vaccine Effectiveness Study in Kenya

OverviewStructured DataIssuesContributors

Contents

Study summaryTimelineTable: Further ResourcesReferences
clinicaltrials.gov/study/NCT01432340
Is a
‌
Clinical study
1

Clinical Study attributes

NCT Number
NCT014323401
Health Conditions in Trial
Influenza
Influenza
1
Trial Recruitment Size
10,0001
Trial Sponsor
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
1
Trial Collaborator
‌
Kenya Medical Research Institute
1
Clinical Trial Start Date
2010
1
Study Completion Date
2013
1
Clinical Trial Study Type
Observational1
Intervention Type
Biological1
Observational Clinical Trial Type
Cohort1
Observational Study Perspective
Prospective1
Official Name
Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak1
Last Updated
September 12, 2011
1

Other attributes

Intervention Treatment
Seasonal influenza vaccine1
Study summary

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.

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Further Resources

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