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NCT Number: NCT01432340

Seasonal Influenza Vaccine Effectiveness Study in Kenya

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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Key information

Conditions

Influenza Infections Influenza Like Illness Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Illness Virus Diseases

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KEMRI/CDC- IEIP surveillance-Asembo, Kisumu, Western, Kenya

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seasonal Influenza Vaccine

Biological

annual recommended Southern Hemisphere vaccine

Other names: Vaxigrip

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gideon Emukule

Fed

Collaborators

  • Kenya Medical Research Institute
  • Kenya Ministry of Health
  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2011
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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