MedTrace Logo

Seasonal Influenza Vaccine Effectiveness Study in Kenya

NCT01432340 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-09-20

No results posted yet for this 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.

Conditions

  • Influenza
  • Influenza Like Illness
  • Severe Acute Respiratory Illness

Interventions

BIOLOGICAL

Seasonal influenza vaccine

annual recommended Southern Hemisphere vaccine

Sponsors & Collaborators

  • Kenya Ministry of Health

    collaborator OTHER_GOV

  • Kenya Medical Research Institute

    collaborator OTHER

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Gideon Emukule

    lead FED

Principal Investigators

  • Mark A Katz, MD · Center for Disease Control and Prevention-Kenya

  • Robert Breiman, MD · Centers for Disease Control and Prevention

  • Joshua Mott, PhD · Centers for Disease Control and Prevention

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-03-18
Completion
2014-03-18

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432340 on ClinicalTrials.gov