GrippeCanadaV3, Main, Exploration, bibRecord, 000098

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

Identifieur interne : 000098 ( Main/Exploration ); précédent : 000097; suivant : 000099

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

Auteurs : Anuradha Madan [États-Unis] ; Murdo Ferguson [Canada] ; Eric Sheldon [États-Unis] ; Nathan Segall [États-Unis] ; Laurence Chu [États-Unis] ; Azhar Toma [Canada] ; Paul Rheault [Canada] ; Damien Friel [Belgique] ; Jyoti Soni [Inde] ; Ping Li [États-Unis] ; Bruce L. Innis [États-Unis] ; Anne Schuind [États-Unis]

Source :

Vaccine [ 1873-2518 ] ; 2017.

RBID : pubmed:28187952

Descripteurs français

KwdFr :
- Adjuvants immunologiques (administration et posologie), Adulte, Adulte d'âge moyen, Animaux, Anticorps antiviraux (sang), Association médicamenteuse, Canada, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Grippe humaine (), Humains, Immunité acquise, Jeune adulte, Mâle, Méthode en simple aveugle, Placebo (administration et posologie), Polysorbates (administration et posologie), Sous-type H7N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets indésirables), Vaccins inactivés (immunologie), Volontaires sains, alpha-Tocophérol (administration et posologie), États-Unis d'Amérique.
MESH :
- administration et posologie : Adjuvants immunologiques, Placebo, Polysorbates, Squalène, Vaccins antigrippaux, Vaccins inactivés, alpha-Tocophérol.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Sous-type H7N1 du virus de la grippe A, Vaccins antigrippaux, Vaccins inactivés.
- sang : Anticorps antiviraux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adulte, Adulte d'âge moyen, Animaux, Association médicamenteuse, Canada, Femelle, Grippe humaine, Humains, Immunité acquise, Jeune adulte, Mâle, Méthode en simple aveugle, Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Volontaires sains, États-Unis d'Amérique.

English descriptors

KwdEn :
- Adaptive Immunity, Adjuvants, Immunologic (administration & dosage), Adult, Animals, Antibodies, Viral (blood), Canada, Drug Combinations, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H7N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Neutralization Tests, Placebos (administration & dosage), Polysorbates (administration & dosage), Single-Blind Method, Squalene (administration & dosage), United States, Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology), Young Adult, alpha-Tocopherol (administration & dosage).
MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Placebos, Polysorbates, Squalene, Vaccines, Inactivated, alpha-Tocopherol.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Viral.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H7N1 Subtype, Influenza Vaccines, Vaccines, Inactivated.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adaptive Immunity, Adult, Animals, Canada, Drug Combinations, Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Male, Middle Aged, Neutralization Tests, Single-Blind Method, United States, Young Adult.

Abstract

BACKGROUND

H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality.

METHODS

In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.75 or 7.5μg hemagglutinin adjuvanted with either AS03

RESULTS

Beneficial AS03 adjuvant effect was demonstrated. Committee for Medical Products for Human Use, and Center for Biologics Evaluation and Research (CBER) criteria were met for all adjuvanted formulations at day 42 (H7N1 HI assay); seroprotection (SPR) and seroconversion rates (SCR) were 88.5-94.8%, mean geometric increase (MGI) 19.2-34.9, and geometric mean titers (GMT) 98.3-180.7. Unadjuvanted H7N1 vaccine did not meet CBER criteria. In adjuvanted groups, antibody titers decreased over time; month 12 SPRs and GMTs were low (2.0-18.8% and 8.1-12.2). MN antibodies showed similar kinetics, with titers persisting at higher range than HI at month 6. All adjuvanted groups showed cross-reactivity against H7N9, with HI responses similar to H7N1. The most frequent solicited symptom in adjuvanted groups was injection site pain (71.2-86.7%); grade 3 solicited symptoms were infrequent. Nine participants reported 17 serious adverse events; none were considered causally related to vaccination.

CONCLUSIONS

Adjuvanted H7N1 vaccine formulations had an acceptable safety profile and induced an antibody response after 2 doses with cross-reactivity to H7N9. ClinicalTrials.gov: NCT01934127.

DOI: 10.1016/j.vaccine.2017.01.054
PubMed: 28187952

Affiliations:

Belgique, Canada, Inde, États-Unis
Maryland, Pennsylvanie, Texas

Links toward previous steps (curation, corpus...)

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to stream Main, to step Curation: 000102

Le document en format XML

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<term>Influenza Vaccines</term>
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<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H7N1 du virus de la grippe A</term>
<term>Vaccins antigrippaux</term>
<term>Vaccins inactivés</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H7N1 Subtype</term>
<term>Influenza Vaccines</term>
<term>Vaccines, Inactivated</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adaptive Immunity</term>
<term>Adult</term>
<term>Animals</term>
<term>Canada</term>
<term>Drug Combinations</term>
<term>Female</term>
<term>Healthy Volunteers</term>
<term>Hemagglutination Inhibition Tests</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neutralization Tests</term>
<term>Single-Blind Method</term>
<term>United States</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Animaux</term>
<term>Association médicamenteuse</term>
<term>Canada</term>
<term>Femelle</term>
<term>Grippe humaine</term>
<term>Humains</term>
<term>Immunité acquise</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en simple aveugle</term>
<term>Tests d'inhibition de l'hémagglutination</term>
<term>Tests de neutralisation</term>
<term>Volontaires sains</term>
<term>États-Unis d'Amérique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.75 or 7.5μg hemagglutinin adjuvanted with either AS03</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Beneficial AS03 adjuvant effect was demonstrated. Committee for Medical Products for Human Use, and Center for Biologics Evaluation and Research (CBER) criteria were met for all adjuvanted formulations at day 42 (H7N1 HI assay); seroprotection (SPR) and seroconversion rates (SCR) were 88.5-94.8%, mean geometric increase (MGI) 19.2-34.9, and geometric mean titers (GMT) 98.3-180.7. Unadjuvanted H7N1 vaccine did not meet CBER criteria. In adjuvanted groups, antibody titers decreased over time; month 12 SPRs and GMTs were low (2.0-18.8% and 8.1-12.2). MN antibodies showed similar kinetics, with titers persisting at higher range than HI at month 6. All adjuvanted groups showed cross-reactivity against H7N9, with HI responses similar to H7N1. The most frequent solicited symptom in adjuvanted groups was injection site pain (71.2-86.7%); grade 3 solicited symptoms were infrequent. Nine participants reported 17 serious adverse events; none were considered causally related to vaccination.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>Adjuvanted H7N1 vaccine formulations had an acceptable safety profile and induced an antibody response after 2 doses with cross-reactivity to H7N9. ClinicalTrials.gov: NCT01934127.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28187952</PMID>
<DateCompleted><Year>2017</Year>
<Month>12</Month>
<Day>13</Day>
</DateCompleted>
<DateRevised><Year>2018</Year>
<Month>02</Month>
<Day>07</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>35</Volume>
<Issue>10</Issue>
<PubDate><Year>2017</Year>
<Month>03</Month>
<Day>07</Day>
</PubDate>
</JournalIssue>
<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
</Journal>
<ArticleTitle>Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>1431-1439</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(17)30119-6</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2017.01.054</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality.</AbstractText>
<AbstractText Label="METHODS">In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.75 or 7.5μg hemagglutinin adjuvanted with either AS03<sub>A</sub>
 or AS03<sub>B</sub>
), 15μg unadjuvanted H7N1 hemagglutinin, or saline placebo, given as 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays, at day 42 (21days post-dose 2), month 6, and month 12 (HI only) for the per-protocol cohorts (398, 379 and 368 participants, respectively). Safety is reported up to month 12.</AbstractText>
<AbstractText Label="RESULTS">Beneficial AS03 adjuvant effect was demonstrated. Committee for Medical Products for Human Use, and Center for Biologics Evaluation and Research (CBER) criteria were met for all adjuvanted formulations at day 42 (H7N1 HI assay); seroprotection (SPR) and seroconversion rates (SCR) were 88.5-94.8%, mean geometric increase (MGI) 19.2-34.9, and geometric mean titers (GMT) 98.3-180.7. Unadjuvanted H7N1 vaccine did not meet CBER criteria. In adjuvanted groups, antibody titers decreased over time; month 12 SPRs and GMTs were low (2.0-18.8% and 8.1-12.2). MN antibodies showed similar kinetics, with titers persisting at higher range than HI at month 6. All adjuvanted groups showed cross-reactivity against H7N9, with HI responses similar to H7N1. The most frequent solicited symptom in adjuvanted groups was injection site pain (71.2-86.7%); grade 3 solicited symptoms were infrequent. Nine participants reported 17 serious adverse events; none were considered causally related to vaccination.</AbstractText>
<AbstractText Label="CONCLUSIONS">Adjuvanted H7N1 vaccine formulations had an acceptable safety profile and induced an antibody response after 2 doses with cross-reactivity to H7N9. ClinicalTrials.gov: NCT01934127.</AbstractText>
<CopyrightInformation>Copyright © 2017. Published by Elsevier Ltd.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Madan</LastName>
<ForeName>Anuradha</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>GSK, 1250 South Collegeville Road, Collegeville, PA 19426, USA. Electronic address: Anu.2.Madan@gsk.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ferguson</LastName>
<ForeName>Murdo</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Colchester Research Group, 68 Robie Street, Truro, Nova Scotia B2N 1L2, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sheldon</LastName>
<ForeName>Eric</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Miami Research Associates, 6141 Sunset Drive Suite 501, Miami 33143, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Segall</LastName>
<ForeName>Nathan</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Clinical Research Atlanta, 175 Country Club Dr. Ste A, Stockbridge 30281, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chu</LastName>
<ForeName>Laurence</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Benchmark Research, 1015 East 32nd Street, Suite 309, Austin, TX 78705, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Toma</LastName>
<ForeName>Azhar</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Manna Research, 2291 Kipling Avenue Suite 117B, Toronto, Ontario M9W 4L6, Canada. Electronic address: azhar.toma@mannaresearch.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rheault</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Medicor Research Inc, 202-1280 Lasalle Blvd, Sudbury, Ontario P3E 1H5, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Friel</LastName>
<ForeName>Damien</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>GSK, 20 Avenue Fleming, 1300 Wavre, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Soni</LastName>
<ForeName>Jyoti</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>GSK Pharmaceuticals Ltd., 5 Embassy Links, SRT Road, Bangalore, India.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Li</LastName>
<ForeName>Ping</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA. Electronic address: ping.li4@pfizer.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Innis</LastName>
<ForeName>Bruce L</ForeName>
<Initials>BL</Initials>
<AffiliationInfo><Affiliation>GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schuind</LastName>
<ForeName>Anne</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT01934127</AccessionNumber>
<AccessionNumber>NCT01934127</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType>
<PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>02</Month>
<Day>07</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="D010919">Placebos</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D015164">Vaccines, Inactivated</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="D056704" MajorTopicYN="N">Adaptive Immunity</DescriptorName>
</MeshHeading>
<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="D000818" MajorTopicYN="N">Animals</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName>
<QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N">Canada</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D064368" MajorTopicYN="N">Healthy Volunteers</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="D057916" MajorTopicYN="N">Influenza A Virus, H7N1 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="Y">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="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009500" MajorTopicYN="N">Neutralization Tests</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016037" MajorTopicYN="N">Single-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N">United States</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D024502" MajorTopicYN="N">alpha-Tocopherol</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">AS03 adjuvant</Keyword>
<Keyword MajorTopicYN="Y">H7 influenza vaccine</Keyword>
<Keyword MajorTopicYN="Y">H7N1</Keyword>
<Keyword MajorTopicYN="Y">H7N9</Keyword>
<Keyword MajorTopicYN="Y">Pandemic flu</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>10</Month>
<Day>19</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2017</Year>
<Month>01</Month>
<Day>19</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2017</Year>
<Month>01</Month>
<Day>20</Day>
</PubMedPubDate>
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<Month>2</Month>
<Day>12</Day>
<Hour>6</Hour>
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<Day>14</Day>
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<PubMedPubDate PubStatus="entrez"><Year>2017</Year>
<Month>2</Month>
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<Hour>6</Hour>
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<ArticleId IdType="doi">10.1016/j.vaccine.2017.01.054</ArticleId>
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<affiliations><list><country><li>Belgique</li>
<li>Canada</li>
<li>Inde</li>
<li>États-Unis</li>
</country>
<region><li>Maryland</li>
<li>Pennsylvanie</li>
<li>Texas</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Madan, Anuradha" sort="Madan, Anuradha" uniqKey="Madan A" first="Anuradha" last="Madan">Anuradha Madan</name>
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<name sortKey="Chu, Laurence" sort="Chu, Laurence" uniqKey="Chu L" first="Laurence" last="Chu">Laurence Chu</name>
<name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L" last="Innis">Bruce L. Innis</name>
<name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name>
<name sortKey="Schuind, Anne" sort="Schuind, Anne" uniqKey="Schuind A" first="Anne" last="Schuind">Anne Schuind</name>
<name sortKey="Segall, Nathan" sort="Segall, Nathan" uniqKey="Segall N" first="Nathan" last="Segall">Nathan Segall</name>
<name sortKey="Sheldon, Eric" sort="Sheldon, Eric" uniqKey="Sheldon E" first="Eric" last="Sheldon">Eric Sheldon</name>
</country>
<country name="Canada"><noRegion><name sortKey="Ferguson, Murdo" sort="Ferguson, Murdo" uniqKey="Ferguson M" first="Murdo" last="Ferguson">Murdo Ferguson</name>
</noRegion>
<name sortKey="Rheault, Paul" sort="Rheault, Paul" uniqKey="Rheault P" first="Paul" last="Rheault">Paul Rheault</name>
<name sortKey="Toma, Azhar" sort="Toma, Azhar" uniqKey="Toma A" first="Azhar" last="Toma">Azhar Toma</name>
</country>
<country name="Belgique"><noRegion><name sortKey="Friel, Damien" sort="Friel, Damien" uniqKey="Friel D" first="Damien" last="Friel">Damien Friel</name>
</noRegion>
</country>
<country name="Inde"><noRegion><name sortKey="Soni, Jyoti" sort="Soni, Jyoti" uniqKey="Soni J" first="Jyoti" last="Soni">Jyoti Soni</name>
</noRegion>
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Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

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