Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children
Identifieur interne : 000043 ( PascalFrancis/Corpus ); précédent : 000042; suivant : 000044Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children
Auteurs : Karen L. Kotloff ; Natasha B. Halasa ; Christopher J. Harrison ; Janet A. Englund ; Emmanuel B. Walter ; James C. King ; C. Buddy Creech ; Sara A. Healy ; Rowena J. Dolor ; Ina Stephens ; Kathryn M. Edwards ; Diana L. Noah ; Heather Hill ; Mark WolffSource :
- The Pediatric infectious disease journal [ 0891-3668 ] ; 2014.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Background: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods: Children received 2 doses of approximately 15 or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. Results: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective hemagglutination inhibition (≥1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.
Notice en format standard (ISO 2709)
Pour connaître la documentation sur le format Inist Standard.
pA |
|
---|
Format Inist (serveur)
NO : | PASCAL 14-0226638 INIST |
---|---|
ET : | Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children |
AU : | KOTLOFF (Karen L.); HALASA (Natasha B.); HARRISON (Christopher J.); ENGLUND (Janet A.); WALTER (Emmanuel B.); KING (James C.); CREECH (C. Buddy); HEALY (Sara A.); DOLOR (Rowena J.); STEPHENS (Ina); EDWARDS (Kathryn M.); NOAH (Diana L.); HILL (Heather); WOLFF (Mark) |
AF : | Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine/Baltimore, MD/Etats-Unis (1 aut., 10 aut.); Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine/Nashville, TN/Etats-Unis (2 aut., 7 aut., 11 aut.); Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City/Kansas City, MO/Etats-Unis (3 aut.); Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital/Seattle, WA/Etats-Unis (4 aut., 8 aut.); Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine/Durham, NC/Etats-Unis (5 aut.); Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine/Baltimore, MD/Etats-Unis (6 aut.); Department of Medicine, Duke University School of Medicine/Durham, NC/Etats-Unis (9 aut.); Southern Research Institute/Birmingham, AL/Etats-Unis (12 aut.); EMMES Corp, Department of Vaccines and Infectious Diseases/Rockville, MD/Etats-Unis (13 aut., 14 aut.) |
DT : | Publication en série; Compte-rendu; Niveau analytique |
SO : | The Pediatric infectious disease journal; ISSN 0891-3668; Coden PIDJEV; Etats-Unis; Da. 2014; Vol. 33; No. 8; Pp. 865-871; Bibl. 54 ref. |
LA : | Anglais |
EA : | Background: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods: Children received 2 doses of approximately 15 or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. Results: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective hemagglutination inhibition (≥1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics. |
CC : | 002B05C02C |
FD : | Grippe; Immunoprophylaxie; Immunologie; Réponse immune; Souche inactivée; Vaccin; Enfant; Prévention; Toxicité; Essai clinique phase II; Nourrisson; Pédiatrie; Pandémie; Virus grippal A(H1N1) |
FG : | Virose; Infection; Homme |
ED : | Influenza; Immunoprophylaxis; Immunology; Immune response; Inactivated strain; Vaccine; Child; Prevention; Toxicity; Phase II trial; Infant; Pediatrics; Influenza A (H1N1) |
EG : | Viral disease; Infection; Human |
SD : | Gripe; Inmunoprofilaxia; Inmunología; Respuesta inmune; Cepa inactivada; Vacuna; Niño; Prevención; Toxicidad; Ensayo clínico fase II; Lactante; Pediatría |
LO : | INIST-20356.354000507656690160 |
ID : | 14-0226638 |
Links to Exploration step
Pascal:14-0226638Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children</title>
<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
<affiliation><inist:fA14 i1="01"><s1>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Halasa, Natasha B" sort="Halasa, Natasha B" uniqKey="Halasa N" first="Natasha B." last="Halasa">Natasha B. Halasa</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Harrison, Christopher J" sort="Harrison, Christopher J" uniqKey="Harrison C" first="Christopher J." last="Harrison">Christopher J. Harrison</name>
<affiliation><inist:fA14 i1="03"><s1>Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City</s1>
<s2>Kansas City, MO</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Englund, Janet A" sort="Englund, Janet A" uniqKey="Englund J" first="Janet A." last="Englund">Janet A. Englund</name>
<affiliation><inist:fA14 i1="04"><s1>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Walter, Emmanuel B" sort="Walter, Emmanuel B" uniqKey="Walter E" first="Emmanuel B." last="Walter">Emmanuel B. Walter</name>
<affiliation><inist:fA14 i1="05"><s1>Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="King, James C" sort="King, James C" uniqKey="King J" first="James C." last="King">James C. King</name>
<affiliation><inist:fA14 i1="06"><s1>Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Creech, C Buddy" sort="Creech, C Buddy" uniqKey="Creech C" first="C. Buddy" last="Creech">C. Buddy Creech</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Healy, Sara A" sort="Healy, Sara A" uniqKey="Healy S" first="Sara A." last="Healy">Sara A. Healy</name>
<affiliation><inist:fA14 i1="04"><s1>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dolor, Rowena J" sort="Dolor, Rowena J" uniqKey="Dolor R" first="Rowena J." last="Dolor">Rowena J. Dolor</name>
<affiliation><inist:fA14 i1="07"><s1>Department of Medicine, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Stephens, Ina" sort="Stephens, Ina" uniqKey="Stephens I" first="Ina" last="Stephens">Ina Stephens</name>
<affiliation><inist:fA14 i1="01"><s1>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M." last="Edwards">Kathryn M. Edwards</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
<affiliation><inist:fA14 i1="08"><s1>Southern Research Institute</s1>
<s2>Birmingham, AL</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
<affiliation><inist:fA14 i1="09"><s1>EMMES Corp, Department of Vaccines and Infectious Diseases</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name>
<affiliation><inist:fA14 i1="09"><s1>EMMES Corp, Department of Vaccines and Infectious Diseases</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">14-0226638</idno>
<date when="2014">2014</date>
<idno type="stanalyst">PASCAL 14-0226638 INIST</idno>
<idno type="RBID">Pascal:14-0226638</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000043</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children</title>
<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
<affiliation><inist:fA14 i1="01"><s1>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Halasa, Natasha B" sort="Halasa, Natasha B" uniqKey="Halasa N" first="Natasha B." last="Halasa">Natasha B. Halasa</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Harrison, Christopher J" sort="Harrison, Christopher J" uniqKey="Harrison C" first="Christopher J." last="Harrison">Christopher J. Harrison</name>
<affiliation><inist:fA14 i1="03"><s1>Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City</s1>
<s2>Kansas City, MO</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Englund, Janet A" sort="Englund, Janet A" uniqKey="Englund J" first="Janet A." last="Englund">Janet A. Englund</name>
<affiliation><inist:fA14 i1="04"><s1>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Walter, Emmanuel B" sort="Walter, Emmanuel B" uniqKey="Walter E" first="Emmanuel B." last="Walter">Emmanuel B. Walter</name>
<affiliation><inist:fA14 i1="05"><s1>Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="King, James C" sort="King, James C" uniqKey="King J" first="James C." last="King">James C. King</name>
<affiliation><inist:fA14 i1="06"><s1>Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Creech, C Buddy" sort="Creech, C Buddy" uniqKey="Creech C" first="C. Buddy" last="Creech">C. Buddy Creech</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Healy, Sara A" sort="Healy, Sara A" uniqKey="Healy S" first="Sara A." last="Healy">Sara A. Healy</name>
<affiliation><inist:fA14 i1="04"><s1>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dolor, Rowena J" sort="Dolor, Rowena J" uniqKey="Dolor R" first="Rowena J." last="Dolor">Rowena J. Dolor</name>
<affiliation><inist:fA14 i1="07"><s1>Department of Medicine, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Stephens, Ina" sort="Stephens, Ina" uniqKey="Stephens I" first="Ina" last="Stephens">Ina Stephens</name>
<affiliation><inist:fA14 i1="01"><s1>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M." last="Edwards">Kathryn M. Edwards</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
<affiliation><inist:fA14 i1="08"><s1>Southern Research Institute</s1>
<s2>Birmingham, AL</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
<affiliation><inist:fA14 i1="09"><s1>EMMES Corp, Department of Vaccines and Infectious Diseases</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name>
<affiliation><inist:fA14 i1="09"><s1>EMMES Corp, Department of Vaccines and Infectious Diseases</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The Pediatric infectious disease journal</title>
<title level="j" type="abbreviated">Pediatr. infect. dis. j.</title>
<idno type="ISSN">0891-3668</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The Pediatric infectious disease journal</title>
<title level="j" type="abbreviated">Pediatr. infect. dis. j.</title>
<idno type="ISSN">0891-3668</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Child</term>
<term>Immune response</term>
<term>Immunology</term>
<term>Immunoprophylaxis</term>
<term>Inactivated strain</term>
<term>Infant</term>
<term>Influenza</term>
<term>Influenza A (H1N1)</term>
<term>Pediatrics</term>
<term>Phase II trial</term>
<term>Prevention</term>
<term>Toxicity</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Grippe</term>
<term>Immunoprophylaxie</term>
<term>Immunologie</term>
<term>Réponse immune</term>
<term>Souche inactivée</term>
<term>Vaccin</term>
<term>Enfant</term>
<term>Prévention</term>
<term>Toxicité</term>
<term>Essai clinique phase II</term>
<term>Nourrisson</term>
<term>Pédiatrie</term>
<term>Pandémie</term>
<term>Virus grippal A(H1N1)</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods: Children received 2 doses of approximately 15 or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. Results: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective hemagglutination inhibition (≥1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0891-3668</s0>
</fA01>
<fA02 i1="01"><s0>PIDJEV</s0>
</fA02>
<fA03 i2="1"><s0>Pediatr. infect. dis. j.</s0>
</fA03>
<fA05><s2>33</s2>
</fA05>
<fA06><s2>8</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>KOTLOFF (Karen L.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>HALASA (Natasha B.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>HARRISON (Christopher J.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>ENGLUND (Janet A.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>WALTER (Emmanuel B.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>KING (James C.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>CREECH (C. Buddy)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>HEALY (Sara A.)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>DOLOR (Rowena J.)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>STEPHENS (Ina)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>EDWARDS (Kathryn M.)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>NOAH (Diana L.)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>HILL (Heather)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>WOLFF (Mark)</s1>
</fA11>
<fA14 i1="01"><s1>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City</s1>
<s2>Kansas City, MO</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Medicine, Duke University School of Medicine</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Southern Research Institute</s1>
<s2>Birmingham, AL</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>EMMES Corp, Department of Vaccines and Infectious Diseases</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</fA14>
<fA20><s1>865-871</s1>
</fA20>
<fA21><s1>2014</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20356</s2>
<s5>354000507656690160</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>54 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>14-0226638</s0>
</fA47>
<fA60><s1>P</s1>
<s3>C</s3>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>The Pediatric infectious disease journal</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods: Children received 2 doses of approximately 15 or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. Results: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective hemagglutination inhibition (≥1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B05C02C</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Grippe</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Influenza</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Gripe</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Immunoprophylaxie</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Immunoprophylaxis</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Inmunoprofilaxia</s0>
<s5>04</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Immunologie</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Immunology</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Inmunología</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Réponse immune</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Immune response</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Respuesta inmune</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Souche inactivée</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Inactivated strain</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Cepa inactivada</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Vaccin</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Vaccine</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Vacuna</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Enfant</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Child</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Niño</s0>
<s5>10</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Prévention</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Prevention</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Prevención</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Essai clinique phase II</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Phase II trial</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0>
<s5>15</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Nourrisson</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Infant</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Lactante</s0>
<s5>16</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Pédiatrie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Pediatrics</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Pediatría</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Pandémie</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Virus grippal A(H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>Influenza A (H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Infección</s0>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Homme</s0>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Human</s0>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Hombre</s0>
</fC07>
<fN21><s1>272</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 14-0226638 INIST</NO>
<ET>Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children</ET>
<AU>KOTLOFF (Karen L.); HALASA (Natasha B.); HARRISON (Christopher J.); ENGLUND (Janet A.); WALTER (Emmanuel B.); KING (James C.); CREECH (C. Buddy); HEALY (Sara A.); DOLOR (Rowena J.); STEPHENS (Ina); EDWARDS (Kathryn M.); NOAH (Diana L.); HILL (Heather); WOLFF (Mark)</AU>
<AF>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine/Baltimore, MD/Etats-Unis (1 aut., 10 aut.); Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine/Nashville, TN/Etats-Unis (2 aut., 7 aut., 11 aut.); Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City/Kansas City, MO/Etats-Unis (3 aut.); Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital/Seattle, WA/Etats-Unis (4 aut., 8 aut.); Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine/Durham, NC/Etats-Unis (5 aut.); Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine/Baltimore, MD/Etats-Unis (6 aut.); Department of Medicine, Duke University School of Medicine/Durham, NC/Etats-Unis (9 aut.); Southern Research Institute/Birmingham, AL/Etats-Unis (12 aut.); EMMES Corp, Department of Vaccines and Infectious Diseases/Rockville, MD/Etats-Unis (13 aut., 14 aut.)</AF>
<DT>Publication en série; Compte-rendu; Niveau analytique</DT>
<SO>The Pediatric infectious disease journal; ISSN 0891-3668; Coden PIDJEV; Etats-Unis; Da. 2014; Vol. 33; No. 8; Pp. 865-871; Bibl. 54 ref.</SO>
<LA>Anglais</LA>
<EA>Background: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods: Children received 2 doses of approximately 15 or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. Results: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective hemagglutination inhibition (≥1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.</EA>
<CC>002B05C02C</CC>
<FD>Grippe; Immunoprophylaxie; Immunologie; Réponse immune; Souche inactivée; Vaccin; Enfant; Prévention; Toxicité; Essai clinique phase II; Nourrisson; Pédiatrie; Pandémie; Virus grippal A(H1N1)</FD>
<FG>Virose; Infection; Homme</FG>
<ED>Influenza; Immunoprophylaxis; Immunology; Immune response; Inactivated strain; Vaccine; Child; Prevention; Toxicity; Phase II trial; Infant; Pediatrics; Influenza A (H1N1)</ED>
<EG>Viral disease; Infection; Human</EG>
<SD>Gripe; Inmunoprofilaxia; Inmunología; Respuesta inmune; Cepa inactivada; Vacuna; Niño; Prevención; Toxicidad; Ensayo clínico fase II; Lactante; Pediatría</SD>
<LO>INIST-20356.354000507656690160</LO>
<ID>14-0226638</ID>
</server>
</inist>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/PandemieGrippaleV1/Data/PascalFrancis/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000043 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 000043 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Sante |area= PandemieGrippaleV1 |flux= PascalFrancis |étape= Corpus |type= RBID |clé= Pascal:14-0226638 |texte= Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children }}
![]() | This area was generated with Dilib version V0.6.34. | ![]() |