Seasonal Influenza Vaccine Effectiveness Study in Kenya

NCT01432340 | Completed

• 1 other identifier: CDC-NCIRD-5933
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Influenza; Influenza Like Illness; Severe Acute Respiratory Illness

Keywords

Influenza; Influenza vaccine; Influenza vaccine effectiveness study

Outcome Measures

Primary Outcomes (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.

  June 2010-March 2013 (3 yrs)

Secondary Outcomes (3)

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

  June 2011-March 2013 (2 yrs)

• Community-reported ILI SARI

  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

  June 2011-March 2013 (2 yrs)

Study Arms (2)

Vaccinated group

Children between 6months- 10years of age who have received the influenza vaccine

Biological: Seasonal influenza vaccine

Unvaccinated group

Eligible children between 6months and 10years who didn't receive the influenza vaccine

Biological: Seasonal influenza vaccine

Interventions

Seasonal influenza vaccine BIOLOGICAL

annual recommended Southern Hemisphere vaccine

Also known as: Vaxigrip

Unvaccinated group; Vaccinated group

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gideon Emukule: lead
• Kenya Ministry of Health: collaborator
• Kenya Medical Research Institute: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (2)

KEMRI/CDC- IEIP surveillance-Asembo

Kisumu, Western, Kenya

Location

KEMRI/CDC IEIP surveillance- Kibera

Nairobi, Kenya

Location

Related Publications (5)

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

  BACKGROUND

• 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.

  PMID: 11892493 BACKGROUND

• 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.

  PMID: 16509764 BACKGROUND

• 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.

  PMID: 19086915 BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal and oropharyngeal swabs.Potentially has DNA and RNA retained.

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: East Africa Influenza Program Director

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 12, 2011
• Study Start: June 1, 2010
• Primary Completion: March 18, 2014
• Study Completion: March 18, 2014
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

KE (2)