Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons A Randomized Clinical Trial
Por:
Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinón-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL and Flu4VEC Study Group
Publicada:
1 ene 2020
Ahead of Print:
5 nov 2019
Resumen:
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.
Filiaciones:
Dbaibo G:
From the American University of Beirut, Beirut, Lebanon
Amanullah A:
GSK, Rockville, Maryland
Claeys C:
GSK, Wavre, Belgium
Izu A:
GSK, Rockville, Maryland
Jain VK:
GSK, King of Prussia, Pennsylvania
Kosalaraksa P:
Khon Kaen University, Khon Kaen, Thailand
Rivera L:
National Autonomous University of Santo Domingo, Santo Domingo, Dominican Republic
Soni J:
GSK, Bangalore, India
Yanni E:
GSK, Rockville, Maryland
Zaman K:
icddr,b, Dhaka, Bangladesh
Acosta B:
Dr Castroviejo Primary Health Care Center, Madrid, Spain
Ariza M:
Centro Médico Dominicano, Santo Domingo, Dominican Republic
Arroba Basanta ML:
Complutense University of Madrid, Spain
Bavdekar A:
KEM Hospital Research Centre, Pune, India
Carmona A:
Instituto Hispalense de Pediatría, Sevilla, Spain
Cousin L:
Tecnologia en Investigacion, San Pedro Sula, Honduras
Danier J:
GSK, Rockville, Maryland
Diaz A:
National Autonomous University of Honduras, Tegucigalpa, Honduras
:
FISABIO-Public Health, Valencia, Spain
Dinleyici EC:
Eskisehir Osmangazi University, Eskisehir, Turkey
Faust SN:
University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
Garcia-Sicilia J:
Hospital Infantil Universitario La Paz, Madrid, Spain
Gomez-Go GD:
Mary Chiles General Hospital, Manila, Philippines
Gonzales MLA:
University of the Philippines, Philippine General Hospital, Manila, Philippines
Hacimustafaoglu M:
Uludag University, Bursa, Turkey
Hughes SM:
Royal Manchester Children's Hospital, Manchester, United Kingdom
Kant S:
Centre for Community Medicine, All India institute of Medical Sciences, New Delhi, India
Lucero M:
Research Institute for Tropical Medicine, Manila, Philippines
Mares Bermudez J:
Institut Pediàtric Marès-Riera, Blanes, Spain
Martinón-Torres F:
Hospital Clínico Universitario de Santiago, Santiago, Spain
Montellano M:
Mary Chiles General Hospital, Manila, Philippines
Prymula R:
Charles University, Prague, School of Medicine, Hradec Kralove, Czech Republic
Puthanakit T:
Center of Postgraduate Medical Education, Warsaw, PolandCenter for Excellence in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand
Ruzkova R:
Medicentrum 6 s.r.o., Prague, Czech Republic
Sadowska-Krawczenko I:
Nicolaus Copernicus University in Torun, Collegium Medicum, Bydgoszcz, Poland and University Hospital No 2, Bydgoszcz, Poland
Szymanski H:
St. Hedwig of Silesia Hospital, Trzebnica, Poland
Ulied A:
EBA Centelles, Barcelona, Spain
Woo W:
GSK, Rockville, Maryland
Schuind A:
GSK, Rockville, Maryland
Innis BL:
GSK, King of Prussia, Pennsylvania
Green Published, hybrid
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