Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children
Identifieur interne : 000127 ( PascalFrancis/Checkpoint ); précédent : 000126; suivant : 000128Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children
Auteurs : Karen L. Kotloff [États-Unis] ; Natasha B. Halasa [États-Unis] ; Christopher J. Harrison [États-Unis] ; Janet A. Englund [États-Unis] ; Emmanuel B. Walter [États-Unis] ; James C. King [États-Unis] ; C. Buddy Creech [États-Unis] ; Sara A. Healy [États-Unis] ; Rowena J. Dolor [États-Unis] ; Ina Stephens [États-Unis] ; Kathryn M. Edwards [États-Unis] ; Diana L. Noah [États-Unis] ; Heather Hill [États-Unis] ; Mark Wolff [États-Unis]Source :
- The Pediatric infectious disease journal [ 0891-3668 ] ; 2014.
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- Pascal (Inist)
- Wicri :
- topic : Immunologie, Vaccin, Enfant, Pédiatrie.
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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.
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King</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Washington (État)</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Stephens, Ina" sort="Stephens, Ina" uniqKey="Stephens I" first="Ina" last="Stephens">Ina Stephens</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="2"><inist:fA14 i1="08"><s1>Southern Research Institute</s1><s2>Birmingham, AL</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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><idno type="wicri:Area/PascalFrancis/Curation">001D76</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000127</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000127</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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Missouri (État)</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Washington (État)</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Washington (État)</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Stephens, Ina" sort="Stephens, Ina" uniqKey="Stephens I" first="Ina" last="Stephens">Ina Stephens</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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 wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="2"><inist:fA14 i1="08"><s1>Southern Research Institute</s1><s2>Birmingham, AL</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name><affiliation wicri:level="2"><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><country>États-Unis</country><placeName><region type="state">Maryland</region></placeName></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><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Immunologie</term><term>Vaccin</term><term>Enfant</term><term>Pédiatrie</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></inist><affiliations><list><country><li>États-Unis</li></country><region><li>Alabama</li><li>Caroline du Nord</li><li>Maryland</li><li>Missouri (État)</li><li>Tennessee</li><li>Washington (État)</li></region></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name></region><name sortKey="Creech, C Buddy" sort="Creech, C Buddy" uniqKey="Creech C" first="C. Buddy" last="Creech">C. Buddy Creech</name><name sortKey="Dolor, Rowena J" sort="Dolor, Rowena J" uniqKey="Dolor R" first="Rowena J." last="Dolor">Rowena J. Dolor</name><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M." last="Edwards">Kathryn M. Edwards</name><name sortKey="Englund, Janet A" sort="Englund, Janet A" uniqKey="Englund J" first="Janet A." last="Englund">Janet A. Englund</name><name sortKey="Halasa, Natasha B" sort="Halasa, Natasha B" uniqKey="Halasa N" first="Natasha B." last="Halasa">Natasha B. Halasa</name><name sortKey="Harrison, Christopher J" sort="Harrison, Christopher J" uniqKey="Harrison C" first="Christopher J." last="Harrison">Christopher J. Harrison</name><name sortKey="Healy, Sara A" sort="Healy, Sara A" uniqKey="Healy S" first="Sara A." last="Healy">Sara A. Healy</name><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><name sortKey="King, James C" sort="King, James C" uniqKey="King J" first="James C." last="King">James C. King</name><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name><name sortKey="Stephens, Ina" sort="Stephens, Ina" uniqKey="Stephens I" first="Ina" last="Stephens">Ina Stephens</name><name sortKey="Walter, Emmanuel B" sort="Walter, Emmanuel B" uniqKey="Walter E" first="Emmanuel B." last="Walter">Emmanuel B. Walter</name><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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