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Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial
G. Dbaibo, A. Amanullah, C. Claeys, A. Izu, VK. Jain, P. Kosalaraksa, L. Rivera, J. Soni, E. Yanni, K. Zaman, B. Acosta, M. Ariza, ML. Arroba Basanta, A. Bavdekar, A. Carmona, L. Cousin, J. Danier, A. Diaz, J. Diez-Domingo, EC. Dinleyici, SN....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Influenza, Human epidemiology prevention & control MeSH
- Outcome Assessment, Health Care MeSH
- Vaccines, Inactivated administration & dosage immunology MeSH
- Geography, Medical MeSH
- Humans MeSH
- Public Health Surveillance MeSH
- Patient Acceptance of Health Care * MeSH
- Seasons MeSH
- Influenza Vaccines administration & dosage immunology MeSH
- Influenza A virus genetics immunology MeSH
- Influenza B virus genetics immunology MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: We evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial. METHODS: The aim of this analysis was to estimate vaccine efficacy (VE) in preventing laboratory-confirmed influenza in each of 5 independent seasonal cohorts (2011-2014), as well as vaccine impact on healthcare utilization in 3 study regions (Europe/Mediterranean, Asia-Pacific and Central America). Healthy children were randomized 1:1 to IIV4 or control vaccines. VE was estimated against influenza confirmed by reverse transcription polymerase chain reaction on nasal swabs. Cultured isolates were characterized as antigenically matched/mismatched to vaccine strains. RESULTS: The total vaccinated cohort included 12,018 children (N = 1777, 2526, 1564, 1501 and 4650 in cohorts 1-5, respectively). For reverse transcription polymerase chain reaction confirmed influenza of any severity (all strains combined), VE in cohorts 1-5 was 57.8%, 52.9%, 73.4%, 30.3% and 41.4%, respectively, with the lower limit of the 95% confidence interval >0 for all estimates. The proportion of vaccine match for all strains combined in each cohort was 0.9%, 79.3%, 72.5%, 24.1% and 28.6%, respectively. Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America. CONCLUSIONS: IIV4 prevented influenza in children 6-35 months of age in each of 5 separate influenza seasons in diverse geographical regions. A possible interaction between VE, degree of vaccine match and socioeconomic status was observed. The IIV4 attenuated the severity of breakthrough influenza illness and reduced healthcare utilization, particularly antibiotic use.
Centre for Community Medicine All India institute of Medical Sciences New Delhi India
Centro Médico Dominicano Santo Domingo Dominican Republic
Charles University Prague School of Medicine Hradec Kralove Czech Republic
Complutense University of Madrid Spain
Dr Castroviejo Primary Health Care Center Madrid Spain
Eskisehir Osmangazi University Eskisehir Turkey
FISABIO Public Health Valencia Spain
From the American University of Beirut Beirut Lebanon
GSK King of Prussia Pennsylvania
Hospital Clínico Universitario de Santiago Santiago Spain
Hospital Infantil Universitario La Paz Madrid Spain
Institut Pediàtric Marès Riera Blanes Spain
Instituto Hispalense de Pediatría Sevilla Spain
KEM Hospital Research Centre Pune India
Khon Kaen University Khon Kaen Thailand
Mary Chiles General Hospital Manila Philippines
Medicentrum 6 s r o Prague Czech Republic
National Autonomous University of Honduras Tegucigalpa Honduras
National Autonomous University of Santo Domingo Santo Domingo Dominican Republic
Research Institute for Tropical Medicine Manila Philippines
Royal Manchester Children's Hospital Manchester United Kingdom
St Hedwig of Silesia Hospital Trzebnica Poland
Tecnologia en Investigacion San Pedro Sula Honduras
Uludag University Bursa Turkey
University of the Philippines Philippine General Hospital Manila Philippines
References provided by Crossref.org
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- $a Dbaibo, Ghassan $u From the American University of Beirut, Beirut, Lebanon.
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