Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population
Identifieur interne : 000157 ( PascalFrancis/Corpus ); précédent : 000156; suivant : 000158Safety 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 ; Richard Fritz ; Eva Maria Pöllabauer ; Daniel Portsmouth ; M. Keith Howard ; Thomas R. Kreil ; Thomas Dvorak ; Sandor Fritsch ; Timo Vesikari ; Javier Diez-Domingo ; Peter Richmond ; BEE WAH LEE ; Otfried Kistner ; Hartmut J. Ehrlich ; P. Noel Barrett ; Gerald AichingerSource :
- The Journal of infectious diseases [ 0022-1899 ] ; 2014.
Descripteurs français
- Pascal (Inist)
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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Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 14-0047758 INIST |
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ET : | Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population |
AU : | VAN DER VELDEN (Maikel V. W.); FRITZ (Richard); PÖLLABAUER (Eva Maria); PORTSMOUTH (Daniel); HOWARD (M. Keith); KREIL (Thomas R.); DVORAK (Thomas); FRITSCH (Sandor); VESIKARI (Timo); DIEZ-DOMINGO (Javier); RICHMOND (Peter); BEE WAH LEE; KISTNER (Otfried); EHRLICH (Hartmut J.); BARRETT (P. Noel); AICHINGER (Gerald) |
AF : | Vaccine Research and Development, Baxter BioScience/Vienna/Autriche (1 aut., 3 aut., 16 aut.); Global Research and Development, Baxter BioScience/Vienna/Autriche (7 aut., 8 aut., 14 aut.); Vaccine Research and Development, Baxter BioScience/Orth/Donau/Autriche (2 aut., 4 aut., 5 aut., 6 aut., 13 aut., 15 aut.); University of Tampere Medical School/Finlande (9 aut.); Centro Superior de Investigación en Salud Pública/Valencia/Espagne (10 aut.); University of Western Australia School of Paediatrics and Child Health/Subiaco/Australie (11 aut.); Vaccine Trials Group, Telethon Institute for Child Health Research/Subiaco/Australie (11 aut.); Princess Margaret Hospital for Children/Subiaco/Australie (11 aut.); The Child and Allergy Clinic, Mount Elizabeth Medical Centre/Singapour (12 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2014; Vol. 209; No. 1; Pp. 12-23; Bibl. 45 ref. |
LA : | Anglais |
EA : | 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. |
CC : | 002A05F04; 002B05 |
FD : | Immunogénicité; Culture cellulaire; Vaccin; Infection; Virus grippal A(H5N1) |
ED : | Immunogenicity; Cell culture; Vaccine; Infection; Influenzavirus A(H5N1) |
SD : | Inmunogenicidad; Cultivo celular; Vacuna; Infección |
LO : | INIST-2052.354000501676190050 |
ID : | 14-0047758 |
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Pascal:14-0047758Le 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>
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<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>
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<fA02 i1="01"><s0>JIDIAQ</s0>
</fA02>
<fA03 i2="1"><s0>J. infect. dis.</s0>
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<fA05><s2>209</s2>
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<fA06><s2>1</s2>
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<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>
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<fA11 i1="01" i2="1"><s1>VAN DER VELDEN (Maikel V. W.)</s1>
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<fA11 i1="02" i2="1"><s1>FRITZ (Richard)</s1>
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<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>
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<fA44><s0>0000</s0>
<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
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<fA47 i1="01" i2="1"><s0>14-0047758</s0>
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<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>
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<s5>05</s5>
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<s5>07</s5>
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<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>
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</fC03>
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</fN21>
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<ET>Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population</ET>
<AU>VAN DER VELDEN (Maikel V. W.); FRITZ (Richard); PÖLLABAUER (Eva Maria); PORTSMOUTH (Daniel); HOWARD (M. Keith); KREIL (Thomas R.); DVORAK (Thomas); FRITSCH (Sandor); VESIKARI (Timo); DIEZ-DOMINGO (Javier); RICHMOND (Peter); BEE WAH LEE; KISTNER (Otfried); EHRLICH (Hartmut J.); BARRETT (P. Noel); AICHINGER (Gerald)</AU>
<AF>Vaccine Research and Development, Baxter BioScience/Vienna/Autriche (1 aut., 3 aut., 16 aut.); Global Research and Development, Baxter BioScience/Vienna/Autriche (7 aut., 8 aut., 14 aut.); Vaccine Research and Development, Baxter BioScience/Orth/Donau/Autriche (2 aut., 4 aut., 5 aut., 6 aut., 13 aut., 15 aut.); University of Tampere Medical School/Finlande (9 aut.); Centro Superior de Investigación en Salud Pública/Valencia/Espagne (10 aut.); University of Western Australia School of Paediatrics and Child Health/Subiaco/Australie (11 aut.); Vaccine Trials Group, Telethon Institute for Child Health Research/Subiaco/Australie (11 aut.); Princess Margaret Hospital for Children/Subiaco/Australie (11 aut.); The Child and Allergy Clinic, Mount Elizabeth Medical Centre/Singapour (12 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2014; Vol. 209; No. 1; Pp. 12-23; Bibl. 45 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002A05F04; 002B05</CC>
<FD>Immunogénicité; Culture cellulaire; Vaccin; Infection; Virus grippal A(H5N1)</FD>
<ED>Immunogenicity; Cell culture; Vaccine; Infection; Influenzavirus A(H5N1)</ED>
<SD>Inmunogenicidad; Cultivo celular; Vacuna; Infección</SD>
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