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Seasonal Influenza Vaccine Effectiveness Study in Kenya

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ClinicalTrials.gov Identifier: NCT01432340
Recruitment Status : Unknown
Verified September 2011 by Mark Katz, Centers for Disease Control and Prevention.
Recruitment status was:  Recruiting
First Posted : September 12, 2011
Last Update Posted : September 12, 2011
Sponsor:
Collaborators:
Kenya Ministry of Health
Kenya Medical Research Institute
MCM Vaccines B.V.
Information provided by (Responsible Party):
Mark Katz, Centers for Disease Control and Prevention

September 7, 2011
September 12, 2011
September 12, 2011
June 2010
Not Provided
Laboratory-confirmed influenza infection [ Time Frame: 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.
Same as current
No Changes Posted
  • Medically attended Influenza Like Illness(ILI) and Severe Acute Respiratory Illness (SARI) [ Time Frame: June 2011-March 2013 (2 yrs) ]
    Look at the number of medically attended ILI and SARI in the unvaccinated group and compare to the vaccinated goup
  • Community-reported ILI SARI [ Time Frame: June 2011- March 2013 (2 yrs) ]
    Look at the number of Community-reported ILI and SARI in the unvaccinated group and compare to the number in the vaccinated group
  • Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members [ Time Frame: June 2011-March 2013 (2 yrs) ]
    Look at the number of Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members in both households that have a vaccinated child versus households that didn't have a vaccinated child
Same as current
Not Provided
Not Provided
 
Seasonal Influenza Vaccine Effectiveness Study in Kenya
Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak
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.

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

  • Medically attended ILI, SARI
  • Community-reported ILI SARI
  • Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members

In Lwak and Kibera, field workers visit households weekly and encourage residents to go to the free clinic if they have respiratory symptoms. Currently, from KEMRI/CDC surveillance data, in Kibera, approximately 57 % of people in the catchment area seek medical care for ILI (Range: 62% children - 52% adults) and of those people who seek care, 72% seek care at Tabitha clinic. In Lwak, approximately 77% of people in the catchment area seek medical care for ILI (Range: 75% children - 80% adults) and of those people who seek care, 34% seek care at Lwak clinic.

The surveillance for ILI and SARI will continue as usual, with weekly field worker (also called community interviewer) household visits, clinic-based surveillance for ILI and SARI at Tabitha clinic and Lwak clinic, and sampling of all patients who meet the case definition for ILI and SARI

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Nasopharyngeal and oropharyngeal swabs.Potentially has DNA and RNA retained.
Non-Probability Sample
Vaccine will be made available to children six months of age to 10 years in the Kibera and Lwak catchment areas enrolled in the International Emerging Infectious Disease Program( IEIP) conducted by KEMRI/CDC.
  • Influenza
  • Influenza Like Illness
  • Severe Acute Respiratory Illness
Biological: Seasonal influenza vaccine
annual recommended Southern Hemisphere vaccine
Other Name: Vaxigrip
  • Vaccinated group
    Children between 6months- 10years of age who have received the influenza vaccine
    Intervention: Biological: Seasonal influenza vaccine
  • Unvaccinated group
    Eligible children between 6months and 10years who didn't receive the influenza vaccine
    Intervention: Biological: Seasonal influenza vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10000
Same as current
March 2013
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 6 months or greater than or equal to 11 years
  • Not enrolled in the IEIP morbidity study
Sexes Eligible for Study: All
6 Months to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
 
NCT01432340
CDC-NCIRD-5933
No
Not Provided
Not Provided
Mark Katz, Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Kenya Ministry of Health
  • Kenya Medical Research Institute
  • MCM Vaccines B.V.
Principal Investigator: Mark A Katz, MD Center for Disease Control and Prevention-Kenya
Principal Investigator: Robert Breiman, MD Centers for Disease Control and Prevention
Principal Investigator: Joshua Mott, PhD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2011