A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects.
Identifieur interne : 000A99 ( PubMed/Corpus ); précédent : 000A98; suivant : 000B00A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects.
Auteurs : H. Czajka ; S. Unal ; S. Ulusoy ; G. Usluer ; A. Strus ; E. Sennaroglu ; J. Guzik ; A. Topeli Iskit ; A. Dargiewicz ; D. Musial ; R. Caylan ; J. Dziduch ; E. Eskioglu ; B. Hasiec ; E. Cwinarowiczliwa ; R. Belli ; I A Abdel-Messih ; J. Beygo ; E. FragapaneSource :
- Journal of preventive medicine and hygiene [ 1121-2233 ] ; 2012.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adult, Age Factors, Aged, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Female, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Neutralization Tests, Polysorbates (administration & dosage), Squalene (administration & dosage), Vaccination (methods), Young Adult.
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- methods : Vaccination.
- prevention & control : Influenza, Human.
- Adult, Age Factors, Aged, Female, Hemagglutination Inhibition Tests, Humans, Male, Middle Aged, Neutralization Tests, Young Adult.
Abstract
Effective planning and preparedness against a possible future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adjuvanted vaccine formulations of relatively lower antigen content.
PubMed: 23362618
Links to Exploration step
pubmed:23362618Le document en format XML
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Strus</name></author><author><name sortKey="Sennaroglu, E" sort="Sennaroglu, E" uniqKey="Sennaroglu E" first="E" last="Sennaroglu">E. Sennaroglu</name></author><author><name sortKey="Guzik, J" sort="Guzik, J" uniqKey="Guzik J" first="J" last="Guzik">J. Guzik</name></author><author><name sortKey="Topeli Iskit, A" sort="Topeli Iskit, A" uniqKey="Topeli Iskit A" first="A" last="Topeli Iskit">A. Topeli Iskit</name></author><author><name sortKey="Dargiewicz, A" sort="Dargiewicz, A" uniqKey="Dargiewicz A" first="A" last="Dargiewicz">A. Dargiewicz</name></author><author><name sortKey="Musial, D" sort="Musial, D" uniqKey="Musial D" first="D" last="Musial">D. Musial</name></author><author><name sortKey="Caylan, R" sort="Caylan, R" uniqKey="Caylan R" first="R" last="Caylan">R. Caylan</name></author><author><name sortKey="Dziduch, J" sort="Dziduch, J" uniqKey="Dziduch J" first="J" last="Dziduch">J. Dziduch</name></author><author><name sortKey="Eskioglu, E" sort="Eskioglu, E" uniqKey="Eskioglu E" first="E" last="Eskioglu">E. Eskioglu</name></author><author><name sortKey="Hasiec, B" sort="Hasiec, B" uniqKey="Hasiec B" first="B" last="Hasiec">B. Hasiec</name></author><author><name sortKey="Cwinarowiczliwa, E" sort="Cwinarowiczliwa, E" uniqKey="Cwinarowiczliwa E" first="E" last="Cwinarowiczliwa">E. Cwinarowiczliwa</name></author><author><name sortKey="Belli, R" sort="Belli, R" uniqKey="Belli R" first="R" last="Belli">R. Belli</name></author><author><name sortKey="Abdel Messih, I A" sort="Abdel Messih, I A" uniqKey="Abdel Messih I" first="I A" last="Abdel-Messih">I A Abdel-Messih</name></author><author><name sortKey="Beygo, J" sort="Beygo, J" uniqKey="Beygo J" first="J" last="Beygo">J. Beygo</name></author><author><name sortKey="Fragapane, E" sort="Fragapane, E" uniqKey="Fragapane E" first="E" last="Fragapane">E. Fragapane</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="RBID">pubmed:23362618</idno><idno type="pmid">23362618</idno><idno type="wicri:Area/PubMed/Corpus">000A99</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000A99</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects.</title><author><name sortKey="Czajka, H" sort="Czajka, H" uniqKey="Czajka H" first="H" last="Czajka">H. Czajka</name><affiliation><nlm:affiliation>Provincial Children's Specialized Hospital, Krakow, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Unal, S" sort="Unal, S" uniqKey="Unal S" first="S" last="Unal">S. Unal</name></author><author><name sortKey="Ulusoy, S" sort="Ulusoy, S" uniqKey="Ulusoy S" first="S" last="Ulusoy">S. Ulusoy</name></author><author><name sortKey="Usluer, G" sort="Usluer, G" uniqKey="Usluer G" first="G" last="Usluer">G. Usluer</name></author><author><name sortKey="Strus, A" sort="Strus, A" uniqKey="Strus A" first="A" last="Strus">A. Strus</name></author><author><name sortKey="Sennaroglu, E" sort="Sennaroglu, E" uniqKey="Sennaroglu E" first="E" last="Sennaroglu">E. Sennaroglu</name></author><author><name sortKey="Guzik, J" sort="Guzik, J" uniqKey="Guzik J" first="J" last="Guzik">J. Guzik</name></author><author><name sortKey="Topeli Iskit, A" sort="Topeli Iskit, A" uniqKey="Topeli Iskit A" first="A" last="Topeli Iskit">A. Topeli Iskit</name></author><author><name sortKey="Dargiewicz, A" sort="Dargiewicz, A" uniqKey="Dargiewicz A" first="A" last="Dargiewicz">A. Dargiewicz</name></author><author><name sortKey="Musial, D" sort="Musial, D" uniqKey="Musial D" first="D" last="Musial">D. Musial</name></author><author><name sortKey="Caylan, R" sort="Caylan, R" uniqKey="Caylan R" first="R" last="Caylan">R. Caylan</name></author><author><name sortKey="Dziduch, J" sort="Dziduch, J" uniqKey="Dziduch J" first="J" last="Dziduch">J. Dziduch</name></author><author><name sortKey="Eskioglu, E" sort="Eskioglu, E" uniqKey="Eskioglu E" first="E" last="Eskioglu">E. Eskioglu</name></author><author><name sortKey="Hasiec, B" sort="Hasiec, B" uniqKey="Hasiec B" first="B" last="Hasiec">B. Hasiec</name></author><author><name sortKey="Cwinarowiczliwa, E" sort="Cwinarowiczliwa, E" uniqKey="Cwinarowiczliwa E" first="E" last="Cwinarowiczliwa">E. Cwinarowiczliwa</name></author><author><name sortKey="Belli, R" sort="Belli, R" uniqKey="Belli R" first="R" last="Belli">R. Belli</name></author><author><name sortKey="Abdel Messih, I A" sort="Abdel Messih, I A" uniqKey="Abdel Messih I" first="I A" last="Abdel-Messih">I A Abdel-Messih</name></author><author><name sortKey="Beygo, J" sort="Beygo, J" uniqKey="Beygo J" first="J" last="Beygo">J. Beygo</name></author><author><name sortKey="Fragapane, E" sort="Fragapane, E" uniqKey="Fragapane E" first="E" last="Fragapane">E. Fragapane</name></author></analytic><series><title level="j">Journal of preventive medicine and hygiene</title><idno type="ISSN">1121-2233</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Antibodies, Neutralizing (blood)</term><term>Antibodies, Viral (blood)</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H1N1 Subtype (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Male</term><term>Middle Aged</term><term>Neutralization Tests</term><term>Polysorbates (administration & dosage)</term><term>Squalene (administration & dosage)</term><term>Vaccination (methods)</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Influenza Vaccines</term><term>Polysorbates</term><term>Squalene</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Neutralizing</term><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neutralization Tests</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Effective planning and preparedness against a possible future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adjuvanted vaccine formulations of relatively lower antigen content.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23362618</PMID><DateCompleted><Year>2013</Year><Month>03</Month><Day>01</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">1121-2233</ISSN><JournalIssue CitedMedium="Print"><Volume>53</Volume><Issue>3</Issue><PubDate><Year>2012</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Journal of preventive medicine and hygiene</Title><ISOAbbreviation>J Prev Med Hyg</ISOAbbreviation></Journal><ArticleTitle>A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects.</ArticleTitle><Pagination><MedlinePgn>136-42</MedlinePgn></Pagination><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Effective planning and preparedness against a possible future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adjuvanted vaccine formulations of relatively lower antigen content.</AbstractText><AbstractText Label="AIM" NlmCategory="OBJECTIVE">This study aimed to demonstrate the non-inferiority of a low-antigen-dose (3.75 μ) [DOSAGE ERROR CORRECTED] A/H5N1 pre-pandemic vaccine compared with a licensed, higher-dose (7.5 mg) formulation in adult and elderly subjects. Immunogenicity was assessed according to European and U.S. licensure criteria.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A total of 722 subjects were randomized in equal numbers to receive either the licensed or low-dose formulation. All subjects received two vaccine doses administered three weeks apart. Immunogenicity was assessed three weeks after the administration of each vaccine dose by hemagglutination inhibition (HI), single radial haemolysis (SRH) and microneutralization assays (MN). Local and systemic reactions were assessed over a seven day period post-vaccination. Adverse events were recorded throughout.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The low-dose vaccine was demonstrated to be non-inferior to the licensed formulation in terms of antibody titres against the vaccine strain. All three European licensure criteria were met by adult subjects in response to the low-dose vaccine; two criteria were met by the elderly age group. Cross-reactive antibodies were detected against the heterologous A/H5N1 antigen strains A/Indonesia/05/05 and A/turkeyTurkey/01/05. Both vaccines were generally well tolerated by both age groups.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">These data demonstrate that a low antigen dose in combination with MF59 adjuvant is adequate for the routine pre-pandemic immunization of adult and elderly subjects.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Czajka</LastName><ForeName>H</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Provincial Children's Specialized Hospital, Krakow, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Unal</LastName><ForeName>S</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Ulusoy</LastName><ForeName>S</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Usluer</LastName><ForeName>G</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Strus</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Sennaroglu</LastName><ForeName>E</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Guzik</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Topeli Iskit</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Dargiewicz</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Musial</LastName><ForeName>D</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Caylan</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Dziduch</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Eskioglu</LastName><ForeName>E</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Hasiec</LastName><ForeName>B</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Cwinarowiczliwa</LastName><ForeName>E</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Belli</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Abdel-Messih</LastName><ForeName>I A</ForeName><Initials>IA</Initials></Author><Author ValidYN="Y"><LastName>Beygo</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Fragapane</LastName><ForeName>E</ForeName><Initials>E</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00914771</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Italy</Country><MedlineTA>J Prev Med Hyg</MedlineTA><NlmUniqueID>9214440</NlmUniqueID><ISSNLinking>1121-2233</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D057134">Antibodies, Neutralizing</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C089950">MF59 oil emulsion</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance></Chemical><Chemical><RegistryNumber>7QWM220FJH</RegistryNumber><NameOfSubstance UI="D013185">Squalene</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="ErratumIn"><RefSource>J Prev Med Hyg. 2012 Dec;53(4):220</RefSource><Note>Dosage error in published abstract; MEDLINE/PubMed abstract corrected</Note></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057134" MajorTopicYN="N">Antibodies, Neutralizing</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</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="Y">administration & dosage</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">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="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009500" MajorTopicYN="N">Neutralization Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>2</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>2</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2013</Year><Month>3</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">23362618</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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