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

Group/Cohort | Intervention/treatment |
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Vaccinated group
Children between 6months- 10years of age who have received the influenza vaccine
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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
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Biological: Seasonal influenza vaccine
annual recommended Southern Hemisphere vaccine
Other Name: Vaxigrip |
- 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.
- 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
Biospecimen Retention: Samples With DNA

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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 |
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

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
Contact: Joshua Mott, PhD | jmott@ke.cdc.gov | ||
Contact: Emmaculate Lebo, MBchB,MPH | elebo@ke.cdc.gov |
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 |
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 |
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 |
Influenza Influenza vaccine Influenza vaccine effectiveness study |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |