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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 14 Jan 2020

At a glance

  • Drugs Influenza virus vaccine (Primary)
  • Indications Flu-like symptoms; Influenza virus infections; Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Most Recent Events

    • 14 Sep 2011 New trial record

Trial Overview

Purpose

This study is investigating the efficacy of a seasonal influenza virus vaccine in decreasing influenza-associated acute respiratory infections in children. The primary endpoint is laboratory-confirmed infuenza infection which will be assessed at three years.

Primary Endpoints

Infection rate (Laboratory-confirmed influenza infection in vaccinated children compared to unvaccinated children.)

Other Endpoints

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

safety_issue: No
description: Look at the number of medically attended ILI and SARI in the unvaccinated group and compare to the vaccinated goup
time_frame: June 2011-March 2013 (2 yrs)

Community-reported ILI SARI

safety_issue: No
description: Look at the number of Community-reported ILI and SARI in the unvaccinated group and compare to the number in the vaccinated group
time_frame: June 2011- March 2013 (2 yrs)

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

safety_issue: No
description: 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
time_frame: June 2011-March 2013 (2 yrs) [1]

Diseases Treated

Indication Qualifiers Patient Segments
Flu-like symptoms prevention -
Influenza virus infections prevention -
Severe acute respiratory syndrome prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 10000

  • Sex male & female
  • Age Group 6 months - 10 years; child; infant

Patient Inclusion Criteria

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

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier Owner
NCT01432340 ClinicalTrials.gov: US National Institutes of Health
CDC-NCIRD5933 -

Organisations

  • Affiliations sanofi pasteur

Trial Dates

  • Initiation Dates

    Actual : 01 Jun 2010

  • End Dates

    Planned : 01 Mar 2013

Other Details

  • Design cohort; multicentre; observational; prospective
  • Phase of Trial Phase IV
  • Location Kenya
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Influenza virus vaccinePrimary Drug Subcutaneous Injection

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

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Breiman R Centers for Disease Control and Prevention Kenya
Debby Caselton KEMRI/CDC IEIP surveillance- Kibera Kenya
Emmaculate Lebo, MBchB, MPH KEMRI/CDC IEIP surveillance- Kibera Kenya
Emmaculate Lebo, MBchB,MPH
elebo@ke.cdc.gov
show details
-
Katz MA Center for Disease Control and Prevention Kenya
Mark A Katz, MD Center for Disease Control and Prevention-Kenya
-
Mott J
Email: jmott@ke.cdc.gov
show details
Centers for Disease Control and Prevention Kenya
Nancy Otieno KEMRI/CDC- IEIP surveillance-Asembo Kenya
Rachel Ochola
rochola@ke.cdc.gov
show details
KEMRI/CDC- IEIP surveillance-Asembo Kenya

Centres

Centre Name Location Trial Centre Country
-
-
-
Center for Disease Control and Prevention
-
Kenya
Center for Disease Control and Prevention-Kenya
-
-
Centers for Disease Control and Prevention
-
Kenya
KEMRI/CDC IEIP surveillance- Kibera Nairobi Kenya
KEMRI/CDC- IEIP surveillance-Asembo Kisumu, Western Kenya
Kenya Medical Research Institute
-
-
Kenya Medical Research Institute
-
-
Kenya Ministry of Health
-
-
Kenya Ministry of Health
-
-
MCM Vaccines B.V.
-
-
Sanofi Pasteur MSD
-
-

Trial History

Event Date Event Type Comment
14 Jan 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 14 Jan 2020
14 Sep 2011 New trial record New trial record Updated 14 Sep 2011

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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