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Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine
J. Danier, L. Rivera, C. Claeys, G. Dbaibo, VK. Jain, P. Kosalaraksa, W. Woo, E. Yanni, K. Zaman, B. Acosta, A. Amanullah, M. Ariza, M. Luisa Arroba Basanta, A. Bavdekar, A. Carmona, L. Cousin, A. Diaz, J. Diez-Domingo, E. Cagri Dinleyici, SN....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie
- MeSH
- chřipka lidská diagnóza epidemiologie prevence a kontrola MeSH
- hospitalizace MeSH
- inaktivované vakcíny aplikace a dávkování imunologie MeSH
- kojenec MeSH
- lidé MeSH
- ochrana veřejného zdraví MeSH
- odds ratio MeSH
- předškolní dítě MeSH
- prevalence MeSH
- proporcionální rizikové modely MeSH
- stupeň závažnosti nemoci MeSH
- určení symptomu MeSH
- vakcinace MeSH
- vakcíny proti chřipce aplikace a dávkování imunologie MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6-35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes. METHODS: This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011-2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018). RESULTS: 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44-0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39-0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case. CONCLUSIONS: In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
American University of Beirut Beirut Lebanon
Center of Postgraduate Medical Education Warsaw Poland
Centre for Community Medicine All India institute of Medical Sciences New Delhi India
Centro Médico Dominicano Santo Domingo Dominican Republic
Complutense University of Madrid Madrid Spain
Dr Castroviejo Primary Health Care Center Madrid Spain
Eskisehir Osmangazi University Eskisehir Turkey
FISABIO Public Health Valencia Spain
From the GSK Rockville Maryland
GSK King of Prussia Pennsylvania
Hospital Clínico Universitario de Santiago Santiago Spain
Hospital Infantil Universitario La Paz Madrid 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
Nicolaus Copernicus University in Torun Collegium Medicum Bydgoszcz Poland
Paediatric Institute Mares Riera Blanes Spain
Research Institute for Tropical Medicine Manila Philippines
St Hedwig of Silesia Hospital Trzebnica Poland
Tecnologia en Investigacion San Pedro Sula Honduras
Uludag University Bursa Turkey
University of Hradec Kralove Hradec Kralove Czech Republic
University of the Philippines Philippine General Hospital Manila Philippines
Citace poskytuje Crossref.org
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- $a Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine / $c J. Danier, L. Rivera, C. Claeys, G. Dbaibo, VK. Jain, P. Kosalaraksa, W. Woo, E. Yanni, K. Zaman, B. Acosta, A. Amanullah, M. Ariza, M. Luisa Arroba Basanta, A. Bavdekar, A. Carmona, L. Cousin, A. Diaz, J. Diez-Domingo, E. Cagri Dinleyici, SN. Faust, J. Garcia-Sicilia, GD. Gomez-Go, L. Antionette Gonzales, M. Hacimustafaoglu, SM. Hughes, A. Izu, T. Jackowska, S. Kant, M. Lucero, J. Mares Bermudez, F. Martinón-Torres, M. Montellano, R. Prymula, T. Puthanakit, R. Ruzkova, I. Sadowska-Krawczenko, J. Soni, H. Szymanski, A. Ulied, A. Schuind, BL. Innis, Flu4VEC Study Group,
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- $a BACKGROUND: In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6-35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes. METHODS: This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011-2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018). RESULTS: 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44-0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39-0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case. CONCLUSIONS: In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
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