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Prevention of vaccine-matched and mismatched influenza in children aged 6-35 months: a multinational randomised trial across five influenza seasons
C. Claeys, K. Zaman, G. Dbaibo, P. Li, A. Izu, P. Kosalaraksa, L. Rivera, B. Acosta, ML. Arroba Basanta, A. Aziz, MA. Cabanero, V. Chandrashekaran, B. Corsaro, L. Cousin, A. Diaz, J. Diez-Domingo, EC. Dinleyici, SN. Faust, D. Friel, J....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- chřipka lidská epidemiologie prevence a kontrola MeSH
- internacionalita MeSH
- jednoduchá slepá metoda MeSH
- kojenec MeSH
- lidé MeSH
- předškolní dítě MeSH
- roční období MeSH
- vakcíny proti chřipce * 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
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Despite the importance of vaccinating children younger than 5 years, few studies evaluating vaccine prevention of influenza have been reported in this age group. We evaluated efficacy of an inactivated quadrivalent influenza vaccine (IIV4) in children aged 6-35 months. METHODS: In this phase 3, observer-blinded, multinational trial, healthy children from 13 countries in Europe, Central America, and Asia were recruited in five independent cohorts, each in a different influenza season. Participants were randomly assigned (1:1) to either IIV4 (15 μg haemagglutinin antigen per strain per 0·5 mL dose; a single dose on day 0 for vaccine-primed children, and two doses, on days 0 and 28, for vaccine-unprimed children) or to one or two doses of a non-influenza control vaccine. Primary endpoints were moderate-to-severe influenza or all influenza (irrespective of disease severity) confirmed by RT-PCR on nasal swabs. Cultured isolates were further characterised as antigenically matched or mismatched to vaccine strains. Efficacy was assessed in the per-protocol cohort and total vaccinated cohort (time-to-event analysis), and safety was assessed in the total vaccinated cohort. FINDINGS: Between Oct 1, 2011, and Dec 31, 2014, 12 018 children were recruited into the total vaccinated cohort (6006 children in the IIV4 group and 6012 children in the control group). 356 (6%) children in the IIV4 group and 693 (12%) children in the control group had at least one case of RT-PCR-confirmed influenza. Of these 1049 influenza strains, 138 (13%) were A/H1N1, 529 (50%) were A/H3N2, 69 (7%) were B/Victoria, and 316 (30%) were B/Yamagata. Overall, 539 (64%) of 848 antigenically characterised isolates were vaccine-mismatched (16 [15%] of 105 for A/H1N1; 368 [97%] of 378 for A/H3N2; 54 [86%] of 63 for B/Victoria; 101 [33%] of 302 for B/Yamagata). Vaccine efficacy was 63% (97·5% CI 52-72) against moderate-to-severe influenza and 50% (42-57) against all influenza in the per-protocol cohort, and 64% (53-73) against moderate-to-severe influenza and 50% (42-57) against all influenza in the total vaccinated cohort. There were no clinically meaningful safety differences between IIV4 and control. INTERPRETATION: IIV4 prevented influenza A and B in children aged 6-35 months despite high levels of vaccine mismatch. Vaccine efficacy was highest against moderate-to-severe disease, which is the most clinically important endpoint associated with greatest burden. FUNDING: GlaxoSmithKline Biologicals SA.
American University of Beirut Beirut Lebanon
Catholic University of Louvain Cliniques Universitaires St Luc Brussels Belgium
Center of Postgraduate Medical Education Warsaw Poland
Centre for Community Medicine All India institute of Medical Sciences New Delhi India
Chulalongkorn University Bangkok Thailand
Complutense University of Madrid Madrid Spain
Dr Castroviejo Primary Health Care Center Madrid Spain
EAP Sardenya IIB Sant Pau Barcelona Spain
Eskisehir Osmangazi University Eskisehir Turkey
FISABIO Public Health Valencia Spain
Hospital Clínico Universitario de Santiago Santiago Spain
Hospital Infantil Universitario La Paz Madrid Spain
Hospital of Antequera Malaga Spain
Instituto Hispalense de Pediatría Sevilla Spain
Jaume 1 University and Illes Columbretes Health Center of Castellón Castellón de la Plana Spain
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
Royal Manchester Children's Hospital Manchester UK
St Hedwig of Silesia Hospital Trzebnica Poland
Tecnologia en Investigacion San Pedro Sula Honduras
University Hospital No 2 Bydgoszcz Poland
University Hospital Southampton NHS Foundation Trust Southampton UK
University of Hradec Kralove Hradec Kralove Czech Republic
University of Southampton Southampton UK
University of the Philippines Philippine General Hospital Manila Philippines
Citace poskytuje Crossref.org
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