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InfluenzaNCT01432340

Seasonal Influenza Vaccine Effectiveness Study in Kenya

An observational study of Influenza and Influenza Like Illness, run by Gideon Emukule at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 10 yearsHealthy volunteers can take part
What is being tested?
Seasonal influenza vaccine
Type of treatment
Vaccines
How many people
10,000 participants
Where
2 sitesKenya
Study dates
Jun 2010to 18 Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

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

Who cannot join

  • Age less than 6 months or greater than or equal to 11 years
  • Not enrolled in the IEIP morbidity study

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

  • KEMRI/CDC- IEIP surveillance-Asembo

    Kisumu, Western

  • KEMRI/CDC IEIP surveillance- Kibera

    Nairobi

Other trials in Kenya

About this study

Official title: 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.

Read the 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

Being tested
Seasonal influenza vaccine
Keywords
Influenza, Influenza vaccine, Influenza vaccine effectiveness study
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seasonal influenza vaccineBiological

    Also called Vaxigrip

    annual recommended Southern Hemisphere vaccine

Study groups in NCT01432340
Study groupRoleWhat they receive
Vaccinated groupChildren between 6months- 10years of age who have received the influenza vaccine
Receives: Biological: Seasonal influenza vaccine
Unvaccinated groupEligible children between 6months and 10years who didn't receive the influenza vaccine
Receives: Biological: Seasonal influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Laboratory-confirmed influenza infection

    Look at the number of vaccinated children who develop laboratory-confirmed influenza infection compared to a matched unvaccinated group of children.

    Measured: June 2010-March 2013 (3 yrs)

Secondary outcomes (3)

  1. Medically attended Influenza Like Illness(ILI) and Severe Acute Respiratory Illness (SARI)

    Look at the number of medically attended ILI and SARI in the unvaccinated group and compare to the vaccinated goup

    Measured: June 2011-March 2013 (2 yrs)

  2. Community-reported ILI SARI

    Look at the number of Community-reported ILI and SARI in the unvaccinated group and compare to the number in the vaccinated group

    Measured: June 2011- March 2013 (2 yrs)

  3. Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members

    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

    Measured: June 2011-March 2013 (2 yrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2011 (estimated)
  2. Study startJun 2010
  3. Primary completion18 Mar 2014
  4. Study completion18 Mar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432340
Sponsor's protocol ID
CDC-NCIRD-5933
Status last verified
Sep 2024
First submitted
7 Sep 2011
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No

Publications

  • World Health Organization. Acute Respiratory Infections (Update September 2009). 2009. Available at http://www.who.int/vaccine_research/diseases/ari/en/print.html

  • Williams BG, Gouws E, Boschi-Pinto C, Bryce J, Dye C. Estimates of world-wide distribution of child deaths from acute respiratory infections. Lancet Infect Dis. 2002 Jan;2(1):25-32. doi: 10.1016/s1473-3099(01)00170-0.

    PubMed 11892493

  • Viboud C, Alonso WJ, Simonsen L. Influenza in tropical regions. PLoS Med. 2006 Apr;3(4):e89. doi: 10.1371/journal.pmed.0030089. Epub 2006 Mar 7.

    PubMed 16509764

  • Belongia EA, Kieke BA, Donahue JG, Greenlee RT, Balish A, Foust A, Lindstrom S, Shay DK; Marshfield Influenza Study Group. Effectiveness of inactivated influenza vaccines varied substantially with antigenic match from the 2004-2005 season to the 2006-2007 season. J Infect Dis. 2009 Jan 15;199(2):159-67. doi: 10.1086/595861.

    PubMed 19086915

  • Center for Disease Control. ACIP Provisional Recommendations for the Use of Influenza Vaccines, March 2, 2010. Available at http://www.immunize.org/acip/

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza and Influenza Like Illness, run by Gideon Emukule at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Laboratory-confirmed influenza infection (time frame: June 2010-March 2013 (3 yrs)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432340, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

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