PandemieGrippaleV1, Main, Exploration, bibRecord, 001025

Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population

Identifieur interne : 001025 ( Main/Exploration ); précédent : 001024; suivant : 001026

Safety 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.

RBID : Pascal:14-0047758

Descripteurs français

Pascal (Inist)
- Immunogénicité, Culture cellulaire, Vaccin, Infection, Virus grippal A(H5N1).
Wicri :
- topic : Vaccin.

English descriptors

KwdEn :
- Cell culture, Immunogenicity, Infection, Influenzavirus A(H5N1), Vaccine.

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.

Affiliations:

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Le document en format XML

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<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>
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<author><name sortKey="Pollabauer, Eva Maria" sort="Pollabauer, Eva Maria" uniqKey="Pollabauer E" first="Eva Maria" last="Pöllabauer">Eva Maria Pöllabauer</name>
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<author><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name>
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<s3>ESP</s3>
<sZ>10 aut.</sZ>
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<s2>Subiaco</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>University of Western Australia School of Paediatrics and Child Health</wicri:noRegion>
</affiliation>
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<sZ>11 aut.</sZ>
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<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Princess Margaret Hospital for Children</wicri:noRegion>
</affiliation>
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<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>
<wicri:noRegion>The Child and Allergy Clinic, Mount Elizabeth Medical Centre</wicri:noRegion>
</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>
<wicri:noRegion>Orth/Donau</wicri:noRegion>
</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="3"><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>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</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>
<wicri:noRegion>Orth/Donau</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Aichinger, Gerald" sort="Aichinger, Gerald" uniqKey="Aichinger G" first="Gerald" last="Aichinger">Gerald Aichinger</name>
<affiliation wicri:level="3"><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>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</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>
<affiliations><list><country><li>Australie</li>
<li>Autriche</li>
<li>Espagne</li>
<li>Finlande</li>
<li>Singapour</li>
</country>
<region><li>Vienne (Autriche)</li>
</region>
<settlement><li>Vienne (Autriche)</li>
</settlement>
</list>
<tree><country name="Autriche"><region name="Vienne (Autriche)"><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>
</region>
<name sortKey="Aichinger, Gerald" sort="Aichinger, Gerald" uniqKey="Aichinger G" first="Gerald" last="Aichinger">Gerald Aichinger</name>
<name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name>
<name sortKey="Dvorak, Thomas" sort="Dvorak, Thomas" uniqKey="Dvorak T" first="Thomas" last="Dvorak">Thomas Dvorak</name>
<name sortKey="Ehrlich, Hartmut J" sort="Ehrlich, Hartmut J" uniqKey="Ehrlich H" first="Hartmut J." last="Ehrlich">Hartmut J. Ehrlich</name>
<name sortKey="Fritsch, Sandor" sort="Fritsch, Sandor" uniqKey="Fritsch S" first="Sandor" last="Fritsch">Sandor Fritsch</name>
<name sortKey="Fritz, Richard" sort="Fritz, Richard" uniqKey="Fritz R" first="Richard" last="Fritz">Richard Fritz</name>
<name sortKey="Howard, M Keith" sort="Howard, M Keith" uniqKey="Howard M" first="M. Keith" last="Howard">M. Keith Howard</name>
<name sortKey="Kistner, Otfried" sort="Kistner, Otfried" uniqKey="Kistner O" first="Otfried" last="Kistner">Otfried Kistner</name>
<name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name>
<name sortKey="Pollabauer, Eva Maria" sort="Pollabauer, Eva Maria" uniqKey="Pollabauer E" first="Eva Maria" last="Pöllabauer">Eva Maria Pöllabauer</name>
<name sortKey="Portsmouth, Daniel" sort="Portsmouth, Daniel" uniqKey="Portsmouth D" first="Daniel" last="Portsmouth">Daniel Portsmouth</name>
</country>
<country name="Finlande"><noRegion><name sortKey="Vesikari, Timo" sort="Vesikari, Timo" uniqKey="Vesikari T" first="Timo" last="Vesikari">Timo Vesikari</name>
</noRegion>
</country>
<country name="Espagne"><noRegion><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Richmond, Peter" sort="Richmond, Peter" uniqKey="Richmond P" first="Peter" last="Richmond">Peter Richmond</name>
</noRegion>
<name sortKey="Richmond, Peter" sort="Richmond, Peter" uniqKey="Richmond P" first="Peter" last="Richmond">Peter Richmond</name>
<name sortKey="Richmond, Peter" sort="Richmond, Peter" uniqKey="Richmond P" first="Peter" last="Richmond">Peter Richmond</name>
</country>
<country name="Singapour"><noRegion><name sortKey="Bee Wah Lee" sort="Bee Wah Lee" uniqKey="Bee Wah Lee" last="Bee Wah Lee">BEE WAH LEE</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population

Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population

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