Seasonal Influenza Vaccine Effectiveness Study in the Kenyan Communities of Kibera and Lwak
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
- 14 Sep 2011 New trial record
Most Recent Events
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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG