tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2019 Nov 5. doi: 10.1097/INF.0000000000002504. [Epub ahead of print] [h=1]Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial.[/h]
Dbaibo G[SUP]1[/SUP], Amanullah A[SUP]2[/SUP], Claeys C[SUP]3[/SUP], Izu A[SUP]2[/SUP], Jain VK[SUP]4[/SUP], Kosalaraksa P[SUP]5[/SUP], Rivera L[SUP]6[/SUP], Soni J[SUP]7[/SUP], Yanni E[SUP]2[/SUP], Zaman K[SUP]8[/SUP], Acosta B[SUP]9[/SUP], Ariza M[SUP]10[/SUP], Arroba Basanta ML[SUP]11[/SUP], Bavdekar A[SUP]12[/SUP], Carmona A[SUP]13[/SUP], Cousin L[SUP]14[/SUP], Danier J[SUP]2[/SUP], Diaz A[SUP]15[/SUP], Diez-Domingo J[SUP]16[/SUP], Dinleyici EC[SUP]17[/SUP], Faust SN[SUP]18[/SUP], Garcia-Sicilia J[SUP]19[/SUP], Gomez-Go GD[SUP]20[/SUP], Gonzales MLA[SUP]21[/SUP], Hacimustafaoglu M[SUP]22[/SUP], Hughes SM[SUP]23[/SUP], Jackowska T, Kant S[SUP]24[/SUP], Lucero M[SUP]25[/SUP], Mares Bermudez J[SUP]26[/SUP], Martin?n-Torres F[SUP]27[/SUP], Montellano M[SUP]20[/SUP], Prymula R[SUP]28[/SUP], Puthanakit T[SUP]29[/SUP], Ruzkova R[SUP]30[/SUP], Sadowska-Krawczenko I[SUP]31[/SUP], Szymanski H[SUP]32[/SUP], Ulied A[SUP]33[/SUP], Woo W[SUP]2[/SUP], Schuind A[SUP]2[/SUP], Innis BL[SUP]4[/SUP]; Flu4VEC Study Group.
[h=3]Author information[/h] 1 From the American University of Beirut, Beirut, Lebanon. 2 GSK, Rockville, Maryland. 3 GSK, Wavre, Belgium. 4 GSK, King of Prussia, Pennsylvania. 5 Khon Kaen University, Khon Kaen, Thailand. 6 National Autonomous University of Santo Domingo, Santo Domingo, Dominican Republic. 7 GSK, Bangalore, India. 8 icddr,b, Dhaka, Bangladesh. 9 Dr Castroviejo Primary Health Care Center, Madrid, Spain. 10 Centro M?dico Dominicano, Santo Domingo, Dominican Republic. 11 Complutense University of Madrid, Spain. 12 KEM Hospital Research Centre, Pune, India. 13 Instituto Hispalense de Pediatr?a, Sevilla, Spain. 14 Tecnologia en Investigacion, San Pedro Sula, Honduras. 15 National Autonomous University of Honduras, Tegucigalpa, Honduras. 16 FISABIO-Public Health, Valencia, Spain. 17 Eskisehir Osmangazi University, Eskisehir, Turkey. 18 University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. 19 Hospital Infantil Universitario La Paz, Madrid, Spain. 20 Mary Chiles General Hospital, Manila, Philippines. 21 University of the Philippines, Philippine General Hospital, Manila, Philippines. 22 Uludag University, Bursa, Turkey. 23 Royal Manchester Children's Hospital, Manchester, United Kingdom. 24 Centre for Community Medicine, All India institute of Medical Sciences, New Delhi, India. 25 Research Institute for Tropical Medicine, Manila, Philippines. 26 Institut Pedi?tric Mar?s-Riera, Blanes, Spain. 27 Hospital Cl?nico Universitario de Santiago, Santiago, Spain. 28 Charles University, Prague, School of Medicine, Hradec Kralove, Czech Republic. 29 Center of Postgraduate Medical Education, Warsaw, PolandCenter for Excellence in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand. 30 Medicentrum 6 s.r.o., Prague, Czech Republic. 31 Nicolaus Copernicus University in Torun, Collegium Medicum, Bydgoszcz, Poland and University Hospital No 2, Bydgoszcz, Poland. 32 St. Hedwig of Silesia Hospital, Trzebnica, Poland. 33 EBA Centelles, Barcelona, Spain.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] We evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
PMID: 31725115 DOI: 10.1097/INF.0000000000002504
Dbaibo G[SUP]1[/SUP], Amanullah A[SUP]2[/SUP], Claeys C[SUP]3[/SUP], Izu A[SUP]2[/SUP], Jain VK[SUP]4[/SUP], Kosalaraksa P[SUP]5[/SUP], Rivera L[SUP]6[/SUP], Soni J[SUP]7[/SUP], Yanni E[SUP]2[/SUP], Zaman K[SUP]8[/SUP], Acosta B[SUP]9[/SUP], Ariza M[SUP]10[/SUP], Arroba Basanta ML[SUP]11[/SUP], Bavdekar A[SUP]12[/SUP], Carmona A[SUP]13[/SUP], Cousin L[SUP]14[/SUP], Danier J[SUP]2[/SUP], Diaz A[SUP]15[/SUP], Diez-Domingo J[SUP]16[/SUP], Dinleyici EC[SUP]17[/SUP], Faust SN[SUP]18[/SUP], Garcia-Sicilia J[SUP]19[/SUP], Gomez-Go GD[SUP]20[/SUP], Gonzales MLA[SUP]21[/SUP], Hacimustafaoglu M[SUP]22[/SUP], Hughes SM[SUP]23[/SUP], Jackowska T, Kant S[SUP]24[/SUP], Lucero M[SUP]25[/SUP], Mares Bermudez J[SUP]26[/SUP], Martin?n-Torres F[SUP]27[/SUP], Montellano M[SUP]20[/SUP], Prymula R[SUP]28[/SUP], Puthanakit T[SUP]29[/SUP], Ruzkova R[SUP]30[/SUP], Sadowska-Krawczenko I[SUP]31[/SUP], Szymanski H[SUP]32[/SUP], Ulied A[SUP]33[/SUP], Woo W[SUP]2[/SUP], Schuind A[SUP]2[/SUP], Innis BL[SUP]4[/SUP]; Flu4VEC Study Group.
[h=3]Author information[/h] 1 From the American University of Beirut, Beirut, Lebanon. 2 GSK, Rockville, Maryland. 3 GSK, Wavre, Belgium. 4 GSK, King of Prussia, Pennsylvania. 5 Khon Kaen University, Khon Kaen, Thailand. 6 National Autonomous University of Santo Domingo, Santo Domingo, Dominican Republic. 7 GSK, Bangalore, India. 8 icddr,b, Dhaka, Bangladesh. 9 Dr Castroviejo Primary Health Care Center, Madrid, Spain. 10 Centro M?dico Dominicano, Santo Domingo, Dominican Republic. 11 Complutense University of Madrid, Spain. 12 KEM Hospital Research Centre, Pune, India. 13 Instituto Hispalense de Pediatr?a, Sevilla, Spain. 14 Tecnologia en Investigacion, San Pedro Sula, Honduras. 15 National Autonomous University of Honduras, Tegucigalpa, Honduras. 16 FISABIO-Public Health, Valencia, Spain. 17 Eskisehir Osmangazi University, Eskisehir, Turkey. 18 University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. 19 Hospital Infantil Universitario La Paz, Madrid, Spain. 20 Mary Chiles General Hospital, Manila, Philippines. 21 University of the Philippines, Philippine General Hospital, Manila, Philippines. 22 Uludag University, Bursa, Turkey. 23 Royal Manchester Children's Hospital, Manchester, United Kingdom. 24 Centre for Community Medicine, All India institute of Medical Sciences, New Delhi, India. 25 Research Institute for Tropical Medicine, Manila, Philippines. 26 Institut Pedi?tric Mar?s-Riera, Blanes, Spain. 27 Hospital Cl?nico Universitario de Santiago, Santiago, Spain. 28 Charles University, Prague, School of Medicine, Hradec Kralove, Czech Republic. 29 Center of Postgraduate Medical Education, Warsaw, PolandCenter for Excellence in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand. 30 Medicentrum 6 s.r.o., Prague, Czech Republic. 31 Nicolaus Copernicus University in Torun, Collegium Medicum, Bydgoszcz, Poland and University Hospital No 2, Bydgoszcz, Poland. 32 St. Hedwig of Silesia Hospital, Trzebnica, Poland. 33 EBA Centelles, Barcelona, Spain.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] We evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
PMID: 31725115 DOI: 10.1097/INF.0000000000002504