Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children
Identifieur interne : 001118 ( Main/Exploration ); précédent : 001117; suivant : 001119Clinical 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.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Immunologie, Vaccin, Enfant, Pédiatrie.
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.
Affiliations:
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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><idno type="wicri:doubleKey">0891-3668:2014:Kotloff K:clinical:and:immune</idno><idno type="wicri:Area/Main/Merge">001128</idno><idno type="wicri:Area/Main/Curation">001118</idno><idno type="wicri:Area/Main/Exploration">001118</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><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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