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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

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Influenza Influenza Like Illness Severe Acute Respiratory Illness Biological: Seasonal influenza vaccine

Detailed Description:

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

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak
Study Start Date : June 2010
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Group/Cohort Intervention/treatment
Vaccinated group
Children between 6months- 10years of age who have received the influenza vaccine
 Biological: Seasonal influenza vaccine
annual recommended Southern Hemisphere vaccine
Other Name: Vaxigrip
Unvaccinated group
Eligible children between 6months and 10years who didn't receive the influenza vaccine
 Biological: Seasonal influenza vaccine
annual recommended Southern Hemisphere vaccine
Other Name: Vaxigrip


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Biospecimen Retention:   Samples With DNA
Nasopharyngeal and oropharyngeal swabs.Potentially has DNA and RNA retained.

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432340


Contacts
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Contact: Joshua Mott, PhD jmott@ke.cdc.gov
Contact: Emmaculate Lebo, MBchB,MPH elebo@ke.cdc.gov

Locations
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Kenya
KEMRI/CDC- IEIP surveillance-Asembo Recruiting
Kisumu, Western, Kenya
Contact: Nancy Otieno       notieno@ke.cdc.gov   
Contact: Rachel Ochola       rochola@ke.cdc.gov   
Sub-Investigator: Nancy Otieno         
Sub-Investigator: Rachel Ochola         
KEMRI/CDC IEIP surveillance- Kibera Recruiting
Nairobi, Kenya
Contact: Deborah Caselton       dcaselton@ke.cdc.gov   
Contact: Emmaculate Lebo       elebo@ke.cdc.gov   
Sub-Investigator: Debby Caselton         
Sub-Investigator: Emmaculate Lebo, MBchB, MPH         
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Ministry of Health
Kenya Medical Research Institute
MCM Vaccines B.V.
Investigators
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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
More Information
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Publications:
World Health Organization. Acute Respiratory Infections (Update September 2009). 2009. Available at http://www.who.int/vaccine_research/diseases/ari/en/print.html
Center for Disease Control. ACIP Provisional Recommendations for the Use of Influenza Vaccines, March 2, 2010. Available at http://www.immunize.org/acip/

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Responsible Party: Mark Katz, Medical Epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01432340    
Other Study ID Numbers: CDC-NCIRD-5933
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011
Keywords provided by Mark Katz, Centers for Disease Control and Prevention:
Influenza
Influenza vaccine
Influenza vaccine effectiveness study
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases