Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population
Identifieur interne : 001C61 ( PascalFrancis/Curation ); précédent : 001C60; suivant : 001C62Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population
Auteurs : Maikel V. W. Van Der Velden [Autriche] ; Richard Fritz [Autriche] ; Eva Maria Pöllabauer [Autriche] ; Daniel Portsmouth [Autriche] ; M. Keith Howard [Autriche] ; Thomas R. Kreil [Autriche] ; Thomas Dvorak [Autriche] ; Sandor Fritsch [Autriche] ; Timo Vesikari [Finlande] ; Javier Diez-Domingo [Espagne] ; Peter Richmond [Australie] ; BEE WAH LEE [Singapour] ; Otfried Kistner [Autriche] ; Hartmut J. Ehrlich [Autriche] ; P. Noel Barrett [Autriche] ; Gerald Aichinger [Autriche]Source :
- The Journal of infectious diseases [ 0022-1899 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Vaccin.
English descriptors
- KwdEn :
Abstract
Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population. Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-μg or 3.75-μg hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(H5N1) vaccine; adolescents aged 9-17 years received a 7.5-μg dose only. A subset of participants received a booster immunization with an A/Indonesia(H5N1) vaccine approximately 1 year later. HA and neuraminidase antibody responses were assessed. Results. Vaccination was safe and well tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5-μg dose of A/Vietnam vaccine induced virus microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥ 1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 μg A/Vietnam vaccine and in 100% of participants after the booster. Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population. Clinical Trials Registration. NCT01052402.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population</title><author><name sortKey="Van Der Velden, Maikel V W" sort="Van Der Velden, Maikel V W" uniqKey="Van Der Velden M" first="Maikel V. W." last="Van Der Velden">Maikel V. W. 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Keith" last="Howard">M. Keith Howard</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Dvorak, Thomas" sort="Dvorak, Thomas" uniqKey="Dvorak T" first="Thomas" last="Dvorak">Thomas Dvorak</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Fritsch, Sandor" sort="Fritsch, Sandor" uniqKey="Fritsch S" first="Sandor" last="Fritsch">Sandor Fritsch</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Vesikari, Timo" sort="Vesikari, Timo" uniqKey="Vesikari T" first="Timo" last="Vesikari">Timo Vesikari</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>University of Tampere Medical School</s1><s3>FIN</s3><sZ>9 aut.</sZ></inist:fA14><country>Finlande</country></affiliation></author><author><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Centro Superior de Investigación en Salud Pública</s1><s2>Valencia</s2><s3>ESP</s3><sZ>10 aut.</sZ></inist:fA14><country>Espagne</country></affiliation></author><author><name sortKey="Richmond, Peter" sort="Richmond, Peter" uniqKey="Richmond P" first="Peter" last="Richmond">Peter Richmond</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Western Australia School of Paediatrics and Child Health</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Vaccine Trials Group, Telethon Institute for Child Health Research</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Princess Margaret Hospital for Children</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Bee Wah Lee" sort="Bee Wah Lee" uniqKey="Bee Wah Lee" last="Bee Wah Lee">BEE WAH LEE</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>The Child and Allergy Clinic, Mount Elizabeth Medical Centre</s1><s3>SGP</s3><sZ>12 aut.</sZ></inist:fA14><country>Singapour</country></affiliation></author><author><name sortKey="Kistner, Otfried" sort="Kistner, Otfried" uniqKey="Kistner O" first="Otfried" last="Kistner">Otfried Kistner</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Ehrlich, Hartmut J" sort="Ehrlich, Hartmut J" uniqKey="Ehrlich H" first="Hartmut J." last="Ehrlich">Hartmut J. Ehrlich</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Aichinger, Gerald" sort="Aichinger, Gerald" uniqKey="Aichinger G" first="Gerald" last="Aichinger">Gerald Aichinger</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0047758</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0047758 INIST</idno><idno type="RBID">Pascal:14-0047758</idno><idno type="wicri:Area/PascalFrancis/Corpus">000157</idno><idno type="wicri:Area/PascalFrancis/Curation">001C61</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population</title><author><name sortKey="Van Der Velden, Maikel V W" sort="Van Der Velden, Maikel V W" uniqKey="Van Der Velden M" first="Maikel V. W." last="Van Der Velden">Maikel V. W. Van Der Velden</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Fritz, Richard" sort="Fritz, Richard" uniqKey="Fritz R" first="Richard" last="Fritz">Richard Fritz</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Pollabauer, Eva Maria" sort="Pollabauer, Eva Maria" uniqKey="Pollabauer E" first="Eva Maria" last="Pöllabauer">Eva Maria Pöllabauer</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Portsmouth, Daniel" sort="Portsmouth, Daniel" uniqKey="Portsmouth D" first="Daniel" last="Portsmouth">Daniel Portsmouth</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Howard, M Keith" sort="Howard, M Keith" uniqKey="Howard M" first="M. Keith" last="Howard">M. Keith Howard</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Dvorak, Thomas" sort="Dvorak, Thomas" uniqKey="Dvorak T" first="Thomas" last="Dvorak">Thomas Dvorak</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Fritsch, Sandor" sort="Fritsch, Sandor" uniqKey="Fritsch S" first="Sandor" last="Fritsch">Sandor Fritsch</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Vesikari, Timo" sort="Vesikari, Timo" uniqKey="Vesikari T" first="Timo" last="Vesikari">Timo Vesikari</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>University of Tampere Medical School</s1><s3>FIN</s3><sZ>9 aut.</sZ></inist:fA14><country>Finlande</country></affiliation></author><author><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Centro Superior de Investigación en Salud Pública</s1><s2>Valencia</s2><s3>ESP</s3><sZ>10 aut.</sZ></inist:fA14><country>Espagne</country></affiliation></author><author><name sortKey="Richmond, Peter" sort="Richmond, Peter" uniqKey="Richmond P" first="Peter" last="Richmond">Peter Richmond</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Western Australia School of Paediatrics and Child Health</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Vaccine Trials Group, Telethon Institute for Child Health Research</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Princess Margaret Hospital for Children</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Bee Wah Lee" sort="Bee Wah Lee" uniqKey="Bee Wah Lee" last="Bee Wah Lee">BEE WAH LEE</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>The Child and Allergy Clinic, Mount Elizabeth Medical Centre</s1><s3>SGP</s3><sZ>12 aut.</sZ></inist:fA14><country>Singapour</country></affiliation></author><author><name sortKey="Kistner, Otfried" sort="Kistner, Otfried" uniqKey="Kistner O" first="Otfried" last="Kistner">Otfried Kistner</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Ehrlich, Hartmut J" sort="Ehrlich, Hartmut J" uniqKey="Ehrlich H" first="Hartmut J." last="Ehrlich">Hartmut J. Ehrlich</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Aichinger, Gerald" sort="Aichinger, Gerald" uniqKey="Aichinger G" first="Gerald" last="Aichinger">Gerald Aichinger</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Autriche</country></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>Cell culture</term><term>Immunogenicity</term><term>Infection</term><term>Influenzavirus A(H5N1)</term><term>Vaccine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Immunogénicité</term><term>Culture cellulaire</term><term>Vaccin</term><term>Infection</term><term>Virus grippal A(H5N1)</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population. Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-μg or 3.75-μg hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(H5N1) vaccine; adolescents aged 9-17 years received a 7.5-μg dose only. A subset of participants received a booster immunization with an A/Indonesia(H5N1) vaccine approximately 1 year later. HA and neuraminidase antibody responses were assessed. Results. Vaccination was safe and well tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5-μg dose of A/Vietnam vaccine induced virus microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥ 1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 μg A/Vietnam vaccine and in 100% of participants after the booster. Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population. Clinical Trials Registration. NCT01052402.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0022-1899</s0></fA01><fA02 i1="01"><s0>JIDIAQ</s0></fA02><fA03 i2="1"><s0>J. infect. dis.</s0></fA03><fA05><s2>209</s2></fA05><fA06><s2>1</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population</s1></fA08><fA11 i1="01" i2="1"><s1>VAN DER VELDEN (Maikel V. W.)</s1></fA11><fA11 i1="02" i2="1"><s1>FRITZ (Richard)</s1></fA11><fA11 i1="03" i2="1"><s1>PÖLLABAUER (Eva Maria)</s1></fA11><fA11 i1="04" i2="1"><s1>PORTSMOUTH (Daniel)</s1></fA11><fA11 i1="05" i2="1"><s1>HOWARD (M. Keith)</s1></fA11><fA11 i1="06" i2="1"><s1>KREIL (Thomas R.)</s1></fA11><fA11 i1="07" i2="1"><s1>DVORAK (Thomas)</s1></fA11><fA11 i1="08" i2="1"><s1>FRITSCH (Sandor)</s1></fA11><fA11 i1="09" i2="1"><s1>VESIKARI (Timo)</s1></fA11><fA11 i1="10" i2="1"><s1>DIEZ-DOMINGO (Javier)</s1></fA11><fA11 i1="11" i2="1"><s1>RICHMOND (Peter)</s1></fA11><fA11 i1="12" i2="1"><s1>BEE WAH LEE</s1></fA11><fA11 i1="13" i2="1"><s1>KISTNER (Otfried)</s1></fA11><fA11 i1="14" i2="1"><s1>EHRLICH (Hartmut J.)</s1></fA11><fA11 i1="15" i2="1"><s1>BARRETT (P. Noel)</s1></fA11><fA11 i1="16" i2="1"><s1>AICHINGER (Gerald)</s1></fA11><fA14 i1="01"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>16 aut.</sZ></fA14><fA14 i1="02"><s1>Global Research and Development, Baxter BioScience</s1><s2>Vienna</s2><s3>AUT</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>14 aut.</sZ></fA14><fA14 i1="03"><s1>Vaccine Research and Development, Baxter BioScience</s1><s2>Orth/Donau</s2><s3>AUT</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>15 aut.</sZ></fA14><fA14 i1="04"><s1>University of Tampere Medical School</s1><s3>FIN</s3><sZ>9 aut.</sZ></fA14><fA14 i1="05"><s1>Centro Superior de Investigación en Salud Pública</s1><s2>Valencia</s2><s3>ESP</s3><sZ>10 aut.</sZ></fA14><fA14 i1="06"><s1>University of Western Australia School of Paediatrics and Child Health</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></fA14><fA14 i1="07"><s1>Vaccine Trials Group, Telethon Institute for Child Health Research</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></fA14><fA14 i1="08"><s1>Princess Margaret Hospital for Children</s1><s2>Subiaco</s2><s3>AUS</s3><sZ>11 aut.</sZ></fA14><fA14 i1="09"><s1>The Child and Allergy Clinic, Mount Elizabeth Medical Centre</s1><s3>SGP</s3><sZ>12 aut.</sZ></fA14><fA20><s1>12-23</s1></fA20><fA21><s1>2014</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>2052</s2><s5>354000501676190050</s5></fA43><fA44><s0>0000</s0><s1>© 2014 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>45 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>14-0047758</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The Journal of infectious diseases</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population. Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-μg or 3.75-μg hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(H5N1) vaccine; adolescents aged 9-17 years received a 7.5-μg dose only. A subset of participants received a booster immunization with an A/Indonesia(H5N1) vaccine approximately 1 year later. HA and neuraminidase antibody responses were assessed. Results. Vaccination was safe and well tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5-μg dose of A/Vietnam vaccine induced virus microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥ 1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 μg A/Vietnam vaccine and in 100% of participants after the booster. Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population. Clinical Trials Registration. NCT01052402.</s0></fC01><fC02 i1="01" i2="X"><s0>002A05F04</s0></fC02><fC02 i1="02" i2="X"><s0>002B05</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Immunogénicité</s0><s5>05</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Immunogenicity</s0><s5>05</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Inmunogenicidad</s0><s5>05</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Culture cellulaire</s0><s5>06</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Cell culture</s0><s5>06</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Cultivo celular</s0><s5>06</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Vaccin</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Vaccine</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Vacuna</s0><s5>07</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Infection</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Infection</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Infección</s0><s5>08</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Virus grippal A(H5N1)</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Influenzavirus A(H5N1)</s0><s4>CD</s4><s5>96</s5></fC03><fN21><s1>055</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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