Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
Identifieur interne : 000298 ( Main/Exploration ); précédent : 000297; suivant : 000299Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
Auteurs : J. Garcia-Sicilia [Espagne] ; P. Gillard ; A. Carmona ; J C Tejedor ; J. Aristegui ; J M Merino ; U. Behre ; A. Caplanusi ; T. Vaman ; I. DieussaertSource :
- Vaccine [ 1873-2518 ] ; 2011.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adjuvants immunologiques (effets indésirables), Adolescent (MeSH), Allemagne (MeSH), Anticorps antiviraux (sang), Association médicamenteuse (MeSH), Enfant (MeSH), Espagne (MeSH), Femelle (MeSH), Grippe humaine (prévention et contrôle), Humains (MeSH), Mâle (MeSH), Pandémies (MeSH), Polysorbates (MeSH), Résultat thérapeutique (MeSH), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (immunologie), Vaccination (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), alpha-Tocophérol (immunologie).
- MESH :
- administration et posologie : Adjuvants immunologiques, Vaccins antigrippaux.
- effets indésirables : Adjuvants immunologiques, Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Squalène, Vaccins antigrippaux, alpha-Tocophérol.
- prévention et contrôle : Grippe humaine.
- sang : Anticorps antiviraux.
- Adolescent, Allemagne, Association médicamenteuse, Enfant, Espagne, Femelle, Humains, Mâle, Pandémies, Polysorbates, Résultat thérapeutique, Vaccination.
- Wicri :
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adjuvants, Immunologic (adverse effects), Adolescent (MeSH), Antibodies, Viral (blood), Child (MeSH), Drug Combinations (MeSH), Female (MeSH), Germany (MeSH), Humans (MeSH), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male (MeSH), Pandemics (MeSH), Polysorbates (MeSH), Spain (MeSH), Squalene (immunology), Treatment Outcome (MeSH), Vaccination (MeSH), alpha-Tocopherol (immunology).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines.
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines, Squalene, alpha-Tocopherol.
- geographic : Germany, Polysorbates, Spain.
- immunology : Influenza A Virus, H1N1 Subtype.
- prevention & control : Influenza, Human.
- Adolescent, Child, Drug Combinations, Female, Humans, Male, Pandemics, Treatment Outcome, Vaccination.
Abstract
Vaccines with acceptable efficacy profile against the H1N1 A/California/7/2009 virus are needed for use in children. The two studies presented here evaluated the immunogenicity and the reactogenicity/safety of A/H1N1/2009 vaccines containing either 3.75 μg haemagglutinin antigen (HA) and AS03(A)-adjuvant (3.75 μg HA/AS03(A) study) (N=210 [53, 57 and 100 in the 3-5, 6-9 and 10-17 years age strata, respectively]) or 1.9 μg HA and AS03(B)-adjuvant (1.9 μg HA/AS03(B) study) (N=244 [61, 65 and 118 in the 3-5, 6-9 and 10-17 years age strata, respectively]), given as two-dose series. Although the haemagglutination inhibition antibody titres were higher in the 3.75 μg HA/AS03(A) study, both vaccine dosages were highly immunogenic and exceeded regulatory acceptance criteria after the first and the second doses. Seroprotection rates reached 100% and seroconversion rates ranged from 98.2% to 99.1% after each dose of both vaccine dosages. Geometric mean titres increased from 456.5 to 1538.5 and from 297.9 to 1106.7 between the first and the second doses in the 3.75 μg HA/AS03(A) study and the 1.9 μg HA/AS03(B) study, respectively. Despite an observed slight increase of the reactogenicity following the second dose in the 3.75 μg HA/AS03(A) study, the vaccines safety profiles were considered clinically acceptable. In conclusion, both dosages of the AS03-adjuvanted A/H1N1/2009 pandemic influenza vaccines were highly immunogenic and well-tolerated in children and adolescents.
DOI: 10.1016/j.vaccine.2011.04.011
PubMed: 21504774
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Dieussaert</name></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adjuvants, Immunologic (adverse effects)</term><term>Adolescent (MeSH)</term><term>Antibodies, Viral (blood)</term><term>Child (MeSH)</term><term>Drug Combinations (MeSH)</term><term>Female (MeSH)</term><term>Germany (MeSH)</term><term>Humans (MeSH)</term><term>Influenza A Virus, H1N1 Subtype (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Male (MeSH)</term><term>Pandemics (MeSH)</term><term>Polysorbates (MeSH)</term><term>Spain (MeSH)</term><term>Squalene (immunology)</term><term>Treatment Outcome (MeSH)</term><term>Vaccination (MeSH)</term><term>alpha-Tocopherol (immunology)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term><term>Adjuvants immunologiques (effets indésirables)</term><term>Adolescent (MeSH)</term><term>Allemagne (MeSH)</term><term>Anticorps antiviraux (sang)</term><term>Association médicamenteuse (MeSH)</term><term>Enfant (MeSH)</term><term>Espagne (MeSH)</term><term>Femelle (MeSH)</term><term>Grippe humaine (prévention et contrôle)</term><term>Humains (MeSH)</term><term>Mâle (MeSH)</term><term>Pandémies (MeSH)</term><term>Polysorbates (MeSH)</term><term>Résultat thérapeutique (MeSH)</term><term>Sous-type H1N1 du virus de la grippe A (immunologie)</term><term>Squalène (immunologie)</term><term>Vaccination (MeSH)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>alpha-Tocophérol (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Influenza Vaccines</term><term>Squalene</term><term>alpha-Tocopherol</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Germany</term><term>Polysorbates</term><term>Spain</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Adjuvants immunologiques</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Adjuvants immunologiques</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H1N1 du virus de la grippe A</term><term>Squalène</term><term>Vaccins antigrippaux</term><term>alpha-Tocophérol</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Child</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Male</term><term>Pandemics</term><term>Treatment Outcome</term><term>Vaccination</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Allemagne</term><term>Association médicamenteuse</term><term>Enfant</term><term>Espagne</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Pandémies</term><term>Polysorbates</term><term>Résultat thérapeutique</term><term>Vaccination</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Allemagne</term><term>Espagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Vaccines with acceptable efficacy profile against the H1N1 A/California/7/2009 virus are needed for use in children. The two studies presented here evaluated the immunogenicity and the reactogenicity/safety of A/H1N1/2009 vaccines containing either 3.75 μg haemagglutinin antigen (HA) and AS03(A)-adjuvant (3.75 μg HA/AS03(A) study) (N=210 [53, 57 and 100 in the 3-5, 6-9 and 10-17 years age strata, respectively]) or 1.9 μg HA and AS03(B)-adjuvant (1.9 μg HA/AS03(B) study) (N=244 [61, 65 and 118 in the 3-5, 6-9 and 10-17 years age strata, respectively]), given as two-dose series. Although the haemagglutination inhibition antibody titres were higher in the 3.75 μg HA/AS03(A) study, both vaccine dosages were highly immunogenic and exceeded regulatory acceptance criteria after the first and the second doses. Seroprotection rates reached 100% and seroconversion rates ranged from 98.2% to 99.1% after each dose of both vaccine dosages. Geometric mean titres increased from 456.5 to 1538.5 and from 297.9 to 1106.7 between the first and the second doses in the 3.75 μg HA/AS03(A) study and the 1.9 μg HA/AS03(B) study, respectively. Despite an observed slight increase of the reactogenicity following the second dose in the 3.75 μg HA/AS03(A) study, the vaccines safety profiles were considered clinically acceptable. In conclusion, both dosages of the AS03-adjuvanted A/H1N1/2009 pandemic influenza vaccines were highly immunogenic and well-tolerated in children and adolescents.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21504774</PMID><DateCompleted><Year>2011</Year><Month>09</Month><Day>30</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>26</Issue><PubDate><Year>2011</Year><Month>Jun</Month><Day>10</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.</ArticleTitle><Pagination><MedlinePgn>4353-61</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2011.04.011</ELocationID><Abstract><AbstractText>Vaccines with acceptable efficacy profile against the H1N1 A/California/7/2009 virus are needed for use in children. The two studies presented here evaluated the immunogenicity and the reactogenicity/safety of A/H1N1/2009 vaccines containing either 3.75 μg haemagglutinin antigen (HA) and AS03(A)-adjuvant (3.75 μg HA/AS03(A) study) (N=210 [53, 57 and 100 in the 3-5, 6-9 and 10-17 years age strata, respectively]) or 1.9 μg HA and AS03(B)-adjuvant (1.9 μg HA/AS03(B) study) (N=244 [61, 65 and 118 in the 3-5, 6-9 and 10-17 years age strata, respectively]), given as two-dose series. Although the haemagglutination inhibition antibody titres were higher in the 3.75 μg HA/AS03(A) study, both vaccine dosages were highly immunogenic and exceeded regulatory acceptance criteria after the first and the second doses. Seroprotection rates reached 100% and seroconversion rates ranged from 98.2% to 99.1% after each dose of both vaccine dosages. Geometric mean titres increased from 456.5 to 1538.5 and from 297.9 to 1106.7 between the first and the second doses in the 3.75 μg HA/AS03(A) study and the 1.9 μg HA/AS03(B) study, respectively. Despite an observed slight increase of the reactogenicity following the second dose in the 3.75 μg HA/AS03(A) study, the vaccines safety profiles were considered clinically acceptable. In conclusion, both dosages of the AS03-adjuvanted A/H1N1/2009 pandemic influenza vaccines were highly immunogenic and well-tolerated in children and adolescents.</AbstractText><CopyrightInformation>Copyright © 2011 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Garcia-Sicilia</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University Children Hospital La Paz, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gillard</LastName><ForeName>P</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Carmona</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Tejedor</LastName><ForeName>J C</ForeName><Initials>JC</Initials></Author><Author ValidYN="Y"><LastName>Aristegui</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Merino</LastName><ForeName>J M</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Behre</LastName><ForeName>U</ForeName><Initials>U</Initials></Author><Author ValidYN="Y"><LastName>Caplanusi</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Vaman</LastName><ForeName>T</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Dieussaert</LastName><ForeName>I</ForeName><Initials>I</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00964158</AccessionNumber><AccessionNumber>NCT00972517</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2011</Year><Month>04</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C550253">ASO3B adjuvant</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance></Chemical><Chemical><RegistryNumber>7QWM220FJH</RegistryNumber><NameOfSubstance UI="D013185">Squalene</NameOfSubstance></Chemical><Chemical><RegistryNumber>H4N855PNZ1</RegistryNumber><NameOfSubstance UI="D024502">alpha-Tocopherol</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005858" MajorTopicYN="N" Type="Geographic">Germany</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N" Type="Geographic">Spain</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D024502" MajorTopicYN="N">alpha-Tocopherol</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2010</Year><Month>11</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2011</Year><Month>03</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2011</Year><Month>04</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2011</Year><Month>4</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>4</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>10</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">21504774</ArticleId><ArticleId IdType="pii">S0264-410X(11)00521-4</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2011.04.011</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li></country><region><li>Communauté de Madrid</li></region><settlement><li>Madrid</li></settlement></list><tree><noCountry><name sortKey="Aristegui, J" sort="Aristegui, J" uniqKey="Aristegui J" first="J" last="Aristegui">J. Aristegui</name><name sortKey="Behre, U" sort="Behre, U" uniqKey="Behre U" first="U" last="Behre">U. Behre</name><name sortKey="Caplanusi, A" sort="Caplanusi, A" uniqKey="Caplanusi A" first="A" last="Caplanusi">A. Caplanusi</name><name sortKey="Carmona, A" sort="Carmona, A" uniqKey="Carmona A" first="A" last="Carmona">A. Carmona</name><name sortKey="Dieussaert, I" sort="Dieussaert, I" uniqKey="Dieussaert I" first="I" last="Dieussaert">I. Dieussaert</name><name sortKey="Gillard, P" sort="Gillard, P" uniqKey="Gillard P" first="P" last="Gillard">P. Gillard</name><name sortKey="Merino, J M" sort="Merino, J M" uniqKey="Merino J" first="J M" last="Merino">J M Merino</name><name sortKey="Tejedor, J C" sort="Tejedor, J C" uniqKey="Tejedor J" first="J C" last="Tejedor">J C Tejedor</name><name sortKey="Vaman, T" sort="Vaman, T" uniqKey="Vaman T" first="T" last="Vaman">T. Vaman</name></noCountry><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Garcia Sicilia, J" sort="Garcia Sicilia, J" uniqKey="Garcia Sicilia J" first="J" last="Garcia-Sicilia">J. Garcia-Sicilia</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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