Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial
Identifieur interne : 001038 ( Main/Merge ); précédent : 001037; suivant : 001039Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial
Auteurs : Terry Nolan [Australie] ; Sumita Roy-Ghanta [États-Unis] ; May Montellano [Philippines] ; Lily Weckx [Brésil] ; Rolando Ulloa-Gutierrez [Costa Rica] ; Eduardo Lazcano-Ponce [Mexique] ; Angkool Kerdpanich [Thaïlande] ; Marco Aurélio Palazzi Safadi [Brésil] ; Aurelio Cruz-Valdez [Mexique] ; Sandra Litao [Philippines] ; FONG SENG LIM [Singapour] ; Abiel Mascare As De Los Santos [Mexique] ; Miguel Angel Rodriguez Weber [Mexique] ; Juan-Carlos Tinoco [Mexique] ; Marcela Hernandez-De Mezerville [Costa Rica] ; Idis Faingezicht [Costa Rica] ; Pensri Kosuwon [Thaïlande] ; Pio Lopez [Colombie] ; Charissa Borja-Tabora [Philippines] ; PING LI [États-Unis] ; Serge Durviaux [Belgique] ; Louis Fries [États-Unis] ; Gary Dubin [États-Unis] ; Thomas Breuer [Belgique] ; Bruce L. Innis [États-Unis] ; David W. Vaughn [Belgique]Source :
- The Journal of infectious diseases [ 0022-1899 ] ; 2014.
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Abstract
Background. The vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010-2011. Methods. A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009 (H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed. Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. The VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%-93.4%). The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group. Conclusion. The 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.
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type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Roy Ghanta, Sumita" sort="Roy Ghanta, Sumita" uniqKey="Roy Ghanta S" first="Sumita" last="Roy-Ghanta">Sumita Roy-Ghanta</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Pediatrics, Mary Chiles General Hospital</s1><s2>Manila</s2><s3>PHL</s3><sZ>3 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aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Palazzi Safadi, Marco Aurelio" sort="Palazzi Safadi, Marco Aurelio" uniqKey="Palazzi Safadi M" first="Marco Aurélio" last="Palazzi Safadi">Marco Aurélio Palazzi Safadi</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Pediatrics, Faculdade de Ciências Médicas da Santa Casa de São Paulo</s1><s3>BRA</s3><sZ>8 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Department of Pediatrics, Faculdade de Ciências Médicas da Santa Casa de São Paulo</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Associação Fundo de Incentivo à Pesquisa</s1><s2>São Paulo</s2><s3>BRA</s3><sZ>8 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Cruz Valdez, Aurelio" sort="Cruz Valdez, Aurelio" uniqKey="Cruz Valdez A" first="Aurelio" last="Cruz-Valdez">Aurelio Cruz-Valdez</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>National Institute of Public Health of Mexico</s1><s2>Cuernavaca Morelos</s2><s3>MEX</s3><sZ>6 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>National Institute of Public Health of Mexico</wicri:noRegion></affiliation></author><author><name sortKey="Litao, Sandra" sort="Litao, Sandra" uniqKey="Litao S" first="Sandra" last="Litao">Sandra Litao</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pediatrics, De La Salle Health Sciences Institute</s1><s2>Dasmariñas City</s2><s3>PHL</s3><sZ>10 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Dasmariñas City</wicri:noRegion></affiliation></author><author><name sortKey="Fong Seng Lim" sort="Fong Seng Lim" uniqKey="Fong Seng Lim" last="Fong Seng Lim">FONG SENG LIM</name><affiliation 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i1="14"><s1>Instituto Nacional de Pediatria de Mexico</s1><s2>Ciudad e Mexico</s2><s3>MEX</s3><sZ>13 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Instituto Nacional de Pediatria de Mexico</wicri:noRegion></affiliation></author><author><name sortKey="Tinoco, Juan Carlos" sort="Tinoco, Juan Carlos" uniqKey="Tinoco J" first="Juan-Carlos" last="Tinoco">Juan-Carlos Tinoco</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Hospital General de Durango</s1><s2>Durango</s2><s3>MEX</s3><sZ>14 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Hospital General de Durango</wicri:noRegion></affiliation></author><author><name sortKey="Hernandez De Mezerville, Marcela" sort="Hernandez De Mezerville, Marcela" uniqKey="Hernandez De Mezerville M" first="Marcela" last="Hernandez-De Mezerville">Marcela Hernandez-De Mezerville</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Instituto Costarricense de Investigaciones Clínicas</s1><s2>San 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aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Khon Kaen</wicri:noRegion></affiliation></author><author><name sortKey="Lopez, Pio" sort="Lopez, Pio" uniqKey="Lopez P" first="Pio" last="Lopez">Pio Lopez</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Centro de Estudios en Infectologia Pediatrica</s1><s2>Cali</s2><s3>COL</s3><sZ>18 aut.</sZ></inist:fA14><country>Colombie</country><wicri:noRegion>Centro de Estudios en Infectologia Pediatrica</wicri:noRegion></affiliation></author><author><name sortKey="Borja Tabora, Charissa" sort="Borja Tabora, Charissa" uniqKey="Borja Tabora C" first="Charissa" last="Borja-Tabora">Charissa Borja-Tabora</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Health, Research Institute for Tropical Medicine</s1><s2>Muntinlupa</s2><s3>PHL</s3><sZ>19 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Muntinlupa</wicri:noRegion></affiliation></author><author><name sortKey="Ping Li" sort="Ping Li" uniqKey="Ping Li" last="Ping Li">PING LI</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Durviaux, Serge" sort="Durviaux, Serge" uniqKey="Durviaux S" first="Serge" last="Durviaux">Serge Durviaux</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>GlaxoSmithKline Vaccines</s1><s2>Wavre</s2><s3>BEL</s3><sZ>21 aut.</sZ><sZ>24 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author><author><name sortKey="Fries, Louis" sort="Fries, Louis" uniqKey="Fries L" first="Louis" last="Fries">Louis Fries</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Novavax</s1><s2>Rockville, Maryland</s2><s3>USA</s3><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Dubin, Gary" sort="Dubin, Gary" uniqKey="Dubin G" first="Gary" last="Dubin">Gary Dubin</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Breuer, Thomas" sort="Breuer, Thomas" uniqKey="Breuer T" first="Thomas" last="Breuer">Thomas Breuer</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>GlaxoSmithKline Vaccines</s1><s2>Wavre</s2><s3>BEL</s3><sZ>21 aut.</sZ><sZ>24 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L." last="Innis">Bruce L. Innis</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Vaughn, David W" sort="Vaughn, David W" uniqKey="Vaughn D" first="David W." last="Vaughn">David W. Vaughn</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>GlaxoSmithKline Vaccines</s1><s2>Rixensart</s2><s3>BEL</s3><sZ>26 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0209958</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0209958 INIST</idno><idno type="RBID">Pascal:14-0209958</idno><idno type="wicri:Area/PascalFrancis/Corpus">000046</idno><idno type="wicri:Area/PascalFrancis/Curation">001D73</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000037</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000037</idno><idno type="wicri:doubleKey">0022-1899:2014:Nolan T:relative:efficacy:of</idno><idno type="wicri:Area/Main/Merge">001038</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial</title><author><name sortKey="Nolan, Terry" sort="Nolan, Terry" uniqKey="Nolan T" first="Terry" last="Nolan">Terry Nolan</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Murdoch Children's Research Institute, University of Melbourne</s1><s2>Carlton</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Melbourne School of Population and Global Health, University of Melbourne</s1><s2>Carlton</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Roy Ghanta, Sumita" sort="Roy Ghanta, Sumita" uniqKey="Roy Ghanta S" first="Sumita" last="Roy-Ghanta">Sumita Roy-Ghanta</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Pediatrics, Mary Chiles General Hospital</s1><s2>Manila</s2><s3>PHL</s3><sZ>3 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Manila</wicri:noRegion></affiliation></author><author><name sortKey="Weckx, Lily" sort="Weckx, Lily" uniqKey="Weckx L" first="Lily" last="Weckx">Lily Weckx</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Pediatric Infectious Diseases, Department of Pediatrics, Universidade Federal de São Paulo</s1><s3>BRA</s3><sZ>4 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Pediatric Infectious Diseases, Department of Pediatrics, Universidade Federal de São Paulo</wicri:noRegion></affiliation></author><author><name sortKey="Ulloa Gutierrez, Rolando" sort="Ulloa Gutierrez, Rolando" uniqKey="Ulloa Gutierrez R" first="Rolando" last="Ulloa-Gutierrez">Rolando Ulloa-Gutierrez</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Instituto Costarricense de Investigaciones Clínicas</s1><s2>San José</s2><s3>CRI</s3><sZ>5 aut.</sZ><sZ>15 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Costa Rica</country><wicri:noRegion>Instituto Costarricense de Investigaciones Clínicas</wicri:noRegion></affiliation></author><author><name sortKey="Lazcano Ponce, Eduardo" sort="Lazcano Ponce, Eduardo" uniqKey="Lazcano Ponce E" first="Eduardo" last="Lazcano-Ponce">Eduardo Lazcano-Ponce</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>National Institute of Public Health of Mexico</s1><s2>Cuernavaca Morelos</s2><s3>MEX</s3><sZ>6 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>National Institute of Public Health of Mexico</wicri:noRegion></affiliation></author><author><name sortKey="Kerdpanich, Angkool" sort="Kerdpanich, Angkool" uniqKey="Kerdpanich A" first="Angkool" last="Kerdpanich">Angkool Kerdpanich</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao Hospital</s1><s2>Bangkok</s2><s3>THA</s3><sZ>7 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Palazzi Safadi, Marco Aurelio" sort="Palazzi Safadi, Marco Aurelio" uniqKey="Palazzi Safadi M" first="Marco Aurélio" last="Palazzi Safadi">Marco Aurélio Palazzi Safadi</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Pediatrics, Faculdade de Ciências Médicas da Santa Casa de São Paulo</s1><s3>BRA</s3><sZ>8 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Department of Pediatrics, Faculdade de Ciências Médicas da Santa Casa de São Paulo</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Associação Fundo de Incentivo à Pesquisa</s1><s2>São Paulo</s2><s3>BRA</s3><sZ>8 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Cruz Valdez, Aurelio" sort="Cruz Valdez, Aurelio" uniqKey="Cruz Valdez A" first="Aurelio" last="Cruz-Valdez">Aurelio Cruz-Valdez</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>National Institute of Public Health of Mexico</s1><s2>Cuernavaca Morelos</s2><s3>MEX</s3><sZ>6 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>National Institute of Public Health of Mexico</wicri:noRegion></affiliation></author><author><name sortKey="Litao, Sandra" sort="Litao, Sandra" uniqKey="Litao S" first="Sandra" last="Litao">Sandra Litao</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pediatrics, De La Salle Health Sciences Institute</s1><s2>Dasmariñas City</s2><s3>PHL</s3><sZ>10 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Dasmariñas City</wicri:noRegion></affiliation></author><author><name sortKey="Fong Seng Lim" sort="Fong Seng Lim" uniqKey="Fong Seng Lim" last="Fong Seng Lim">FONG SENG LIM</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>National Healthcare Group Polyclinics</s1><s3>SGP</s3><sZ>11 aut.</sZ></inist:fA14><country>Singapour</country><wicri:noRegion>National Healthcare Group Polyclinics</wicri:noRegion></affiliation></author><author><name sortKey="De Los Santos, Abiel Mascare As" sort="De Los Santos, Abiel Mascare As" uniqKey="De Los Santos A" first="Abiel Mascare As" last="De Los Santos">Abiel Mascare As De Los Santos</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Servicios Medicos Universidad Autonoma de Nuevo Leon</s1><s2>Monterrey</s2><s3>MEX</s3><sZ>12 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Servicios Medicos Universidad Autonoma de Nuevo Leon</wicri:noRegion></affiliation></author><author><name sortKey="Rodriguez Weber, Miguel Angel" sort="Rodriguez Weber, Miguel Angel" uniqKey="Rodriguez Weber M" first="Miguel Angel" last="Rodriguez Weber">Miguel Angel Rodriguez Weber</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Instituto Nacional de Pediatria de Mexico</s1><s2>Ciudad e Mexico</s2><s3>MEX</s3><sZ>13 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Instituto Nacional de Pediatria de Mexico</wicri:noRegion></affiliation></author><author><name sortKey="Tinoco, Juan Carlos" sort="Tinoco, Juan Carlos" uniqKey="Tinoco J" first="Juan-Carlos" last="Tinoco">Juan-Carlos Tinoco</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Hospital General de Durango</s1><s2>Durango</s2><s3>MEX</s3><sZ>14 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Hospital General de Durango</wicri:noRegion></affiliation></author><author><name sortKey="Hernandez De Mezerville, Marcela" sort="Hernandez De Mezerville, Marcela" uniqKey="Hernandez De Mezerville M" first="Marcela" last="Hernandez-De Mezerville">Marcela Hernandez-De Mezerville</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Instituto Costarricense de Investigaciones Clínicas</s1><s2>San José</s2><s3>CRI</s3><sZ>5 aut.</sZ><sZ>15 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Costa Rica</country><wicri:noRegion>Instituto Costarricense de Investigaciones Clínicas</wicri:noRegion></affiliation></author><author><name sortKey="Faingezicht, Idis" sort="Faingezicht, Idis" uniqKey="Faingezicht I" first="Idis" last="Faingezicht">Idis Faingezicht</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Instituto Costarricense de Investigaciones Clínicas</s1><s2>San José</s2><s3>CRI</s3><sZ>5 aut.</sZ><sZ>15 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Costa Rica</country><wicri:noRegion>Instituto Costarricense de Investigaciones Clínicas</wicri:noRegion></affiliation></author><author><name sortKey="Kosuwon, Pensri" sort="Kosuwon, Pensri" uniqKey="Kosuwon P" first="Pensri" last="Kosuwon">Pensri Kosuwon</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Pediatrics, Faculty of Medicine, Khon Kaen University</s1><s2>Khon Kaen</s2><s3>THA</s3><sZ>17 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Khon Kaen</wicri:noRegion></affiliation></author><author><name sortKey="Lopez, Pio" sort="Lopez, Pio" uniqKey="Lopez P" first="Pio" last="Lopez">Pio Lopez</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Centro de Estudios en Infectologia Pediatrica</s1><s2>Cali</s2><s3>COL</s3><sZ>18 aut.</sZ></inist:fA14><country>Colombie</country><wicri:noRegion>Centro de Estudios en Infectologia Pediatrica</wicri:noRegion></affiliation></author><author><name sortKey="Borja Tabora, Charissa" sort="Borja Tabora, Charissa" uniqKey="Borja Tabora C" first="Charissa" last="Borja-Tabora">Charissa Borja-Tabora</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Health, Research Institute for Tropical Medicine</s1><s2>Muntinlupa</s2><s3>PHL</s3><sZ>19 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Muntinlupa</wicri:noRegion></affiliation></author><author><name sortKey="Ping Li" sort="Ping Li" uniqKey="Ping Li" last="Ping Li">PING LI</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Durviaux, Serge" sort="Durviaux, Serge" uniqKey="Durviaux S" first="Serge" last="Durviaux">Serge Durviaux</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>GlaxoSmithKline Vaccines</s1><s2>Wavre</s2><s3>BEL</s3><sZ>21 aut.</sZ><sZ>24 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author><author><name sortKey="Fries, Louis" sort="Fries, Louis" uniqKey="Fries L" first="Louis" last="Fries">Louis Fries</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Novavax</s1><s2>Rockville, Maryland</s2><s3>USA</s3><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Dubin, Gary" sort="Dubin, Gary" uniqKey="Dubin G" first="Gary" last="Dubin">Gary Dubin</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Breuer, Thomas" sort="Breuer, Thomas" uniqKey="Breuer T" first="Thomas" last="Breuer">Thomas Breuer</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>GlaxoSmithKline Vaccines</s1><s2>Wavre</s2><s3>BEL</s3><sZ>21 aut.</sZ><sZ>24 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L." last="Innis">Bruce L. Innis</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>GlaxoSmithKline Vaccines, King of Prussia</s1><s2>Pennsylvania</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>20 aut.</sZ><sZ>23 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Vaughn, David W" sort="Vaughn, David W" uniqKey="Vaughn D" first="David W." last="Vaughn">David W. Vaughn</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>GlaxoSmithKline Vaccines</s1><s2>Rixensart</s2><s3>BEL</s3><sZ>26 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">The Journal of infectious diseases</title><title level="j" type="abbreviated">J. infect. dis.</title><idno type="ISSN">0022-1899</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The Journal of infectious diseases</title><title level="j" type="abbreviated">J. infect. dis.</title><idno type="ISSN">0022-1899</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Child</term><term>Efficiency</term><term>Immunological adjuvant</term><term>Infection</term><term>Influenza A</term><term>Influenza A virus</term><term>Vaccine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Virus grippal A</term><term>Efficacité</term><term>Adjuvant immunologique</term><term>Vaccin</term><term>Enfant</term><term>Infection</term><term>Grippe A</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term><term>Enfant</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background. The vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010-2011. Methods. A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009 (H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed. Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. The VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%-93.4%). The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group. Conclusion. The 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Brésil</li><li>Colombie</li><li>Costa Rica</li><li>Mexique</li><li>Philippines</li><li>Singapour</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>Maryland</li><li>Pennsylvanie</li><li>Victoria (État)</li><li>État de São Paulo</li></region><settlement><li>Melbourne</li><li>São Paulo</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Australie"><region name="Victoria (État)"><name sortKey="Nolan, Terry" sort="Nolan, Terry" uniqKey="Nolan T" first="Terry" last="Nolan">Terry Nolan</name></region><name sortKey="Nolan, Terry" sort="Nolan, Terry" uniqKey="Nolan T" first="Terry" last="Nolan">Terry Nolan</name></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Roy Ghanta, Sumita" sort="Roy Ghanta, Sumita" uniqKey="Roy Ghanta S" first="Sumita" last="Roy-Ghanta">Sumita Roy-Ghanta</name></region><name sortKey="Dubin, Gary" sort="Dubin, Gary" uniqKey="Dubin G" first="Gary" last="Dubin">Gary Dubin</name><name sortKey="Fries, Louis" sort="Fries, Louis" uniqKey="Fries L" first="Louis" last="Fries">Louis Fries</name><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L." last="Innis">Bruce L. Innis</name><name sortKey="Ping Li" sort="Ping Li" uniqKey="Ping Li" last="Ping Li">PING LI</name></country><country name="Philippines"><noRegion><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name></noRegion><name sortKey="Borja Tabora, Charissa" sort="Borja Tabora, Charissa" uniqKey="Borja Tabora C" first="Charissa" last="Borja-Tabora">Charissa Borja-Tabora</name><name sortKey="Litao, Sandra" sort="Litao, Sandra" uniqKey="Litao S" first="Sandra" last="Litao">Sandra Litao</name></country><country name="Brésil"><noRegion><name sortKey="Weckx, Lily" sort="Weckx, Lily" uniqKey="Weckx L" first="Lily" last="Weckx">Lily Weckx</name></noRegion><name sortKey="Palazzi Safadi, Marco Aurelio" sort="Palazzi Safadi, Marco Aurelio" uniqKey="Palazzi Safadi M" first="Marco Aurélio" last="Palazzi Safadi">Marco Aurélio Palazzi Safadi</name><name sortKey="Palazzi Safadi, Marco Aurelio" sort="Palazzi Safadi, Marco Aurelio" uniqKey="Palazzi Safadi M" first="Marco Aurélio" last="Palazzi Safadi">Marco Aurélio Palazzi Safadi</name></country><country name="Costa Rica"><noRegion><name sortKey="Ulloa Gutierrez, Rolando" sort="Ulloa Gutierrez, Rolando" uniqKey="Ulloa Gutierrez R" first="Rolando" last="Ulloa-Gutierrez">Rolando Ulloa-Gutierrez</name></noRegion><name sortKey="Faingezicht, Idis" sort="Faingezicht, Idis" uniqKey="Faingezicht I" first="Idis" last="Faingezicht">Idis Faingezicht</name><name sortKey="Hernandez De Mezerville, Marcela" sort="Hernandez De Mezerville, Marcela" uniqKey="Hernandez De Mezerville M" first="Marcela" last="Hernandez-De Mezerville">Marcela Hernandez-De Mezerville</name></country><country name="Mexique"><noRegion><name sortKey="Lazcano Ponce, Eduardo" sort="Lazcano Ponce, Eduardo" uniqKey="Lazcano Ponce E" first="Eduardo" last="Lazcano-Ponce">Eduardo Lazcano-Ponce</name></noRegion><name sortKey="Cruz Valdez, Aurelio" sort="Cruz Valdez, Aurelio" uniqKey="Cruz Valdez A" first="Aurelio" last="Cruz-Valdez">Aurelio Cruz-Valdez</name><name sortKey="De Los Santos, Abiel Mascare As" sort="De Los Santos, Abiel Mascare As" uniqKey="De Los Santos A" first="Abiel Mascare As" last="De Los Santos">Abiel Mascare As De Los Santos</name><name sortKey="Rodriguez Weber, Miguel Angel" sort="Rodriguez Weber, Miguel Angel" uniqKey="Rodriguez Weber M" first="Miguel Angel" last="Rodriguez Weber">Miguel Angel Rodriguez Weber</name><name sortKey="Tinoco, Juan Carlos" sort="Tinoco, Juan Carlos" uniqKey="Tinoco J" first="Juan-Carlos" last="Tinoco">Juan-Carlos Tinoco</name></country><country name="Thaïlande"><noRegion><name sortKey="Kerdpanich, Angkool" sort="Kerdpanich, Angkool" uniqKey="Kerdpanich A" first="Angkool" last="Kerdpanich">Angkool Kerdpanich</name></noRegion><name sortKey="Kosuwon, Pensri" sort="Kosuwon, Pensri" uniqKey="Kosuwon P" first="Pensri" last="Kosuwon">Pensri Kosuwon</name></country><country name="Singapour"><noRegion><name sortKey="Fong Seng Lim" sort="Fong Seng Lim" uniqKey="Fong Seng Lim" last="Fong Seng Lim">FONG SENG LIM</name></noRegion></country><country name="Colombie"><noRegion><name sortKey="Lopez, Pio" sort="Lopez, Pio" uniqKey="Lopez P" first="Pio" last="Lopez">Pio Lopez</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Durviaux, Serge" sort="Durviaux, Serge" uniqKey="Durviaux S" first="Serge" last="Durviaux">Serge Durviaux</name></noRegion><name sortKey="Breuer, Thomas" sort="Breuer, Thomas" uniqKey="Breuer T" first="Thomas" last="Breuer">Thomas Breuer</name><name sortKey="Vaughn, David W" sort="Vaughn, David W" uniqKey="Vaughn D" first="David W." last="Vaughn">David W. Vaughn</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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