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 : 001575 ( Ncbi/Merge ); précédent : 001574; suivant : 001576A 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 [Pologne] ; 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.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Anticorps neutralisants (sang), Facteurs de l'âge, Femelle, Grippe humaine (), Humains, Jeune adulte, Mâle, Polysorbates (administration et posologie), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Sujet âgé, Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccination (), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (immunologie).
- MESH :
- administration et posologie : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- sang : Anticorps antiviraux, Anticorps neutralisants.
- Adulte, Adulte d'âge moyen, Facteurs de l'âge, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Sujet âgé, Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccination.
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 toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000A99
- to stream PubMed, to step Curation: 000A99
- to stream PubMed, to step Checkpoint: 000D55
Links to Exploration step
pubmed:23362618Le document en format XML
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<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>
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<keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps antiviraux (sang)</term>
<term>Anticorps neutralisants (sang)</term>
<term>Facteurs de l'âge</term>
<term>Femelle</term>
<term>Grippe humaine ()</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Polysorbates (administration et posologie)</term>
<term>Sous-type H1N1 du virus de la grippe A (immunologie)</term>
<term>Squalène (administration et posologie)</term>
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<term>Tests d'inhibition de l'hémagglutination</term>
<term>Tests de neutralisation</term>
<term>Vaccination ()</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (immunologie)</term>
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<term>Influenza Vaccines</term>
<term>Polysorbates</term>
<term>Squalene</term>
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<term>Squalène</term>
<term>Vaccins antigrippaux</term>
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<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H1N1 du virus de la grippe A</term>
<term>Vaccins antigrippaux</term>
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<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term>
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<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>
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<term>Facteurs de l'âge</term>
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<term>Grippe humaine</term>
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<term>Mâle</term>
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<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>
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<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>
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<ForeName>A</ForeName>
<Initials>A</Initials>
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<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>
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<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>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
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<MedlineTA>J Prev Med Hyg</MedlineTA>
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<ISSNLinking>1121-2233</ISSNLinking>
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<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D057134">Antibodies, Neutralizing</NameOfSubstance>
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<NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance>
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<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
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<NameOfSubstance UI="C089950">MF59 oil emulsion</NameOfSubstance>
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<NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance>
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<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>
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<MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<MeshHeading><DescriptorName UI="D057134" MajorTopicYN="N">Antibodies, Neutralizing</DescriptorName>
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<MeshHeading><DescriptorName UI="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</DescriptorName>
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<affiliations><list><country><li>Pologne</li>
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<tree><noCountry><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>
<name sortKey="Belli, R" sort="Belli, R" uniqKey="Belli R" first="R" last="Belli">R. Belli</name>
<name sortKey="Beygo, J" sort="Beygo, J" uniqKey="Beygo J" first="J" last="Beygo">J. Beygo</name>
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<name sortKey="Cwinarowiczliwa, E" sort="Cwinarowiczliwa, E" uniqKey="Cwinarowiczliwa E" first="E" last="Cwinarowiczliwa">E. Cwinarowiczliwa</name>
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<name sortKey="Dziduch, J" sort="Dziduch, J" uniqKey="Dziduch J" first="J" last="Dziduch">J. Dziduch</name>
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<name sortKey="Fragapane, E" sort="Fragapane, E" uniqKey="Fragapane E" first="E" last="Fragapane">E. Fragapane</name>
<name sortKey="Guzik, J" sort="Guzik, J" uniqKey="Guzik J" first="J" last="Guzik">J. Guzik</name>
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<name sortKey="Sennaroglu, E" sort="Sennaroglu, E" uniqKey="Sennaroglu E" first="E" last="Sennaroglu">E. Sennaroglu</name>
<name sortKey="Strus, A" sort="Strus, A" uniqKey="Strus A" first="A" last="Strus">A. Strus</name>
<name sortKey="Topeli Iskit, A" sort="Topeli Iskit, A" uniqKey="Topeli Iskit A" first="A" last="Topeli Iskit">A. Topeli Iskit</name>
<name sortKey="Ulusoy, S" sort="Ulusoy, S" uniqKey="Ulusoy S" first="S" last="Ulusoy">S. Ulusoy</name>
<name sortKey="Unal, S" sort="Unal, S" uniqKey="Unal S" first="S" last="Unal">S. Unal</name>
<name sortKey="Usluer, G" sort="Usluer, G" uniqKey="Usluer G" first="G" last="Usluer">G. Usluer</name>
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<country name="Pologne"><noRegion><name sortKey="Czajka, H" sort="Czajka, H" uniqKey="Czajka H" first="H" last="Czajka">H. Czajka</name>
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