Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.
Identifieur interne : 002E02 ( PubMed/Corpus ); précédent : 002E01; suivant : 002E03Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.
Auteurs : Josefina B. Cadorna-Carlos ; Terry Nolan ; Charissa Fay Borja-Tabora ; Jaime Santos ; M Cecilia Montalban ; Ferdinandus J. De Looze ; Peter Eizenberg ; Stephen Hall ; Martin Dupuy ; Yanee Hutagalung ; Stéphanie Pépin ; Melanie SavilleSource :
- Vaccine [ 1873-2518 ] ; 2015.
English descriptors
- KwdEn :
- Adolescent, Adult, Antibodies, Viral (blood), Australia, Child, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Hemagglutination Inhibition Tests, Humans, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Neutralization Tests, Philippines, Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology), Young Adult.
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines, Vaccines, Inactivated.
- geographic : Australia, Philippines.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Child, Double-Blind Method, Female, Hemagglutination Inhibition Tests, Humans, Male, Middle Aged, Neutralization Tests, Young Adult.
Abstract
Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.
DOI: 10.1016/j.vaccine.2015.03.065
PubMed: 25843270
Links to Exploration step
pubmed:25843270Le document en format XML
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Electronic address: t.nolan@unimelb.edu.au.</nlm:affiliation></affiliation></author><author><name sortKey="Borja Tabora, Charissa Fay" sort="Borja Tabora, Charissa Fay" uniqKey="Borja Tabora C" first="Charissa Fay" last="Borja-Tabora">Charissa Fay Borja-Tabora</name><affiliation><nlm:affiliation>Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, Metro Manila, Philippines. Electronic address: cbtabora@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Santos, Jaime" sort="Santos, Jaime" uniqKey="Santos J" first="Jaime" last="Santos">Jaime Santos</name><affiliation><nlm:affiliation>Philippine Children's Medical Center, Agham Road, Quezon City, Metro Manila, Philippines. Electronic address: jimson2@me.com.</nlm:affiliation></affiliation></author><author><name sortKey="Montalban, M Cecilia" sort="Montalban, M Cecilia" uniqKey="Montalban M" first="M Cecilia" last="Montalban">M Cecilia Montalban</name><affiliation><nlm:affiliation>Our Lady of Remedies Clinic, Manila, Philippines. Electronic address: csmontalban@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="De Looze, Ferdinandus J" sort="De Looze, Ferdinandus J" uniqKey="De Looze F" first="Ferdinandus J" last="De Looze">Ferdinandus J. De Looze</name><affiliation><nlm:affiliation>AusTrials, 14 Primrose Street, Sherwood, Queensland 4075, Australia; School of Medicine, University of Queensland, Queensland 4072, Australia. Electronic address: freddelooze@austrials.com.au.</nlm:affiliation></affiliation></author><author><name sortKey="Eizenberg, Peter" sort="Eizenberg, Peter" uniqKey="Eizenberg P" first="Peter" last="Eizenberg">Peter Eizenberg</name><affiliation><nlm:affiliation>Doctors of Ivanhoe, 131 Upper Heidelberg Rd, Ivanhoe, Victoria 3079, Australia. Electronic address: peter@dr131.com.au.</nlm:affiliation></affiliation></author><author><name sortKey="Hall, Stephen" sort="Hall, Stephen" uniqKey="Hall S" first="Stephen" last="Hall">Stephen Hall</name><affiliation><nlm:affiliation>Emeritus Research, 291 Wattletree Rd, Malvern East, Victoria 3145, Australia. Electronic address: stephenhall@emeritusresearch.com.</nlm:affiliation></affiliation></author><author><name sortKey="Dupuy, Martin" sort="Dupuy, Martin" uniqKey="Dupuy M" first="Martin" last="Dupuy">Martin Dupuy</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofipasteur.com.</nlm:affiliation></affiliation></author><author><name sortKey="Hutagalung, Yanee" sort="Hutagalung, Yanee" uniqKey="Hutagalung Y" first="Yanee" last="Hutagalung">Yanee Hutagalung</name><affiliation><nlm:affiliation>Sanofi Pasteur, 6 Raffles Quay, 048580, Singapore. Electronic address: buddy.bello@gmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Pepin, Stephanie" sort="Pepin, Stephanie" uniqKey="Pepin S" first="Stéphanie" last="Pépin">Stéphanie Pépin</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.</nlm:affiliation></affiliation></author><author><name sortKey="Saville, Melanie" sort="Saville, Melanie" uniqKey="Saville M" first="Melanie" last="Saville">Melanie Saville</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Melanie.Saville@sanofipasteur.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25843270</idno><idno type="pmid">25843270</idno><idno type="doi">10.1016/j.vaccine.2015.03.065</idno><idno type="wicri:Area/PubMed/Corpus">002E02</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002E02</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.</title><author><name sortKey="Cadorna Carlos, Josefina B" sort="Cadorna Carlos, Josefina B" uniqKey="Cadorna Carlos J" first="Josefina B" last="Cadorna-Carlos">Josefina B. Cadorna-Carlos</name><affiliation><nlm:affiliation>University of the East Ramon Magsaysay Memorial Medical Center, 64 Aurora Boulevard, Barangay Doña Imelda, Quezon City, Philippines. Electronic address: jccarlosmd@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Nolan, Terry" sort="Nolan, Terry" uniqKey="Nolan T" first="Terry" last="Nolan">Terry Nolan</name><affiliation><nlm:affiliation>Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3010, Australia. Electronic address: t.nolan@unimelb.edu.au.</nlm:affiliation></affiliation></author><author><name sortKey="Borja Tabora, Charissa Fay" sort="Borja Tabora, Charissa Fay" uniqKey="Borja Tabora C" first="Charissa Fay" last="Borja-Tabora">Charissa Fay Borja-Tabora</name><affiliation><nlm:affiliation>Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, Metro Manila, Philippines. Electronic address: cbtabora@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Santos, Jaime" sort="Santos, Jaime" uniqKey="Santos J" first="Jaime" last="Santos">Jaime Santos</name><affiliation><nlm:affiliation>Philippine Children's Medical Center, Agham Road, Quezon City, Metro Manila, Philippines. Electronic address: jimson2@me.com.</nlm:affiliation></affiliation></author><author><name sortKey="Montalban, M Cecilia" sort="Montalban, M Cecilia" uniqKey="Montalban M" first="M Cecilia" last="Montalban">M Cecilia Montalban</name><affiliation><nlm:affiliation>Our Lady of Remedies Clinic, Manila, Philippines. Electronic address: csmontalban@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="De Looze, Ferdinandus J" sort="De Looze, Ferdinandus J" uniqKey="De Looze F" first="Ferdinandus J" last="De Looze">Ferdinandus J. De Looze</name><affiliation><nlm:affiliation>AusTrials, 14 Primrose Street, Sherwood, Queensland 4075, Australia; School of Medicine, University of Queensland, Queensland 4072, Australia. Electronic address: freddelooze@austrials.com.au.</nlm:affiliation></affiliation></author><author><name sortKey="Eizenberg, Peter" sort="Eizenberg, Peter" uniqKey="Eizenberg P" first="Peter" last="Eizenberg">Peter Eizenberg</name><affiliation><nlm:affiliation>Doctors of Ivanhoe, 131 Upper Heidelberg Rd, Ivanhoe, Victoria 3079, Australia. Electronic address: peter@dr131.com.au.</nlm:affiliation></affiliation></author><author><name sortKey="Hall, Stephen" sort="Hall, Stephen" uniqKey="Hall S" first="Stephen" last="Hall">Stephen Hall</name><affiliation><nlm:affiliation>Emeritus Research, 291 Wattletree Rd, Malvern East, Victoria 3145, Australia. Electronic address: stephenhall@emeritusresearch.com.</nlm:affiliation></affiliation></author><author><name sortKey="Dupuy, Martin" sort="Dupuy, Martin" uniqKey="Dupuy M" first="Martin" last="Dupuy">Martin Dupuy</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofipasteur.com.</nlm:affiliation></affiliation></author><author><name sortKey="Hutagalung, Yanee" sort="Hutagalung, Yanee" uniqKey="Hutagalung Y" first="Yanee" last="Hutagalung">Yanee Hutagalung</name><affiliation><nlm:affiliation>Sanofi Pasteur, 6 Raffles Quay, 048580, Singapore. Electronic address: buddy.bello@gmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Pepin, Stephanie" sort="Pepin, Stephanie" uniqKey="Pepin S" first="Stéphanie" last="Pépin">Stéphanie Pépin</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.</nlm:affiliation></affiliation></author><author><name sortKey="Saville, Melanie" sort="Saville, Melanie" uniqKey="Saville M" first="Melanie" last="Saville">Melanie Saville</name><affiliation><nlm:affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Melanie.Saville@sanofipasteur.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Antibodies, Viral (blood)</term><term>Australia</term><term>Child</term><term>Double-Blind Method</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</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</term><term>Middle Aged</term><term>Neutralization Tests</term><term>Philippines</term><term>Vaccines, Inactivated (administration & dosage)</term><term>Vaccines, Inactivated (adverse effects)</term><term>Vaccines, Inactivated (immunology)</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</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>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Australia</term><term>Philippines</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</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" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Child</term><term>Double-Blind Method</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">Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25843270</PMID><DateCreated><Year>2015</Year><Month>05</Month><Day>02</Day></DateCreated><DateCompleted><Year>2016</Year><Month>01</Month><Day>19</Day></DateCompleted><DateRevised><Year>2015</Year><Month>05</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>33</Volume><Issue>21</Issue><PubDate><Year>2015</Year><Month>May</Month><Day>15</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.</ArticleTitle><Pagination><MedlinePgn>2485-92</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2015.03.065</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(15)00384-9</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults.</AbstractText><AbstractText Label="CLINICAL TRIAL REGISTRY NUMBER" NlmCategory="BACKGROUND">NCT01481454.</AbstractText><CopyrightInformation>Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cadorna-Carlos</LastName><ForeName>Josefina B</ForeName><Initials>JB</Initials><AffiliationInfo><Affiliation>University of the East Ramon Magsaysay Memorial Medical Center, 64 Aurora Boulevard, Barangay Doña Imelda, Quezon City, Philippines. Electronic address: jccarlosmd@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nolan</LastName><ForeName>Terry</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3010, Australia. Electronic address: t.nolan@unimelb.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Borja-Tabora</LastName><ForeName>Charissa Fay</ForeName><Initials>CF</Initials><AffiliationInfo><Affiliation>Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, Metro Manila, Philippines. Electronic address: cbtabora@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Santos</LastName><ForeName>Jaime</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Philippine Children's Medical Center, Agham Road, Quezon City, Metro Manila, Philippines. Electronic address: jimson2@me.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Montalban</LastName><ForeName>M Cecilia</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Our Lady of Remedies Clinic, Manila, Philippines. Electronic address: csmontalban@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Looze</LastName><ForeName>Ferdinandus J</ForeName><Initials>FJ</Initials><AffiliationInfo><Affiliation>AusTrials, 14 Primrose Street, Sherwood, Queensland 4075, Australia; School of Medicine, University of Queensland, Queensland 4072, Australia. Electronic address: freddelooze@austrials.com.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eizenberg</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Doctors of Ivanhoe, 131 Upper Heidelberg Rd, Ivanhoe, Victoria 3079, Australia. Electronic address: peter@dr131.com.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hall</LastName><ForeName>Stephen</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Emeritus Research, 291 Wattletree Rd, Malvern East, Victoria 3145, Australia. Electronic address: stephenhall@emeritusresearch.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dupuy</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofipasteur.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hutagalung</LastName><ForeName>Yanee</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Sanofi Pasteur, 6 Raffles Quay, 048580, Singapore. Electronic address: buddy.bello@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pépin</LastName><ForeName>Stéphanie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Saville</LastName><ForeName>Melanie</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Melanie.Saville@sanofipasteur.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01481454</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>04</Month><Day>02</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="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001315" MajorTopicYN="N" Type="Geographic">Australia</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</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="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></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="D010679" MajorTopicYN="N" Type="Geographic">Philippines</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></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Immunogenicity</Keyword><Keyword MajorTopicYN="N">Influenza</Keyword><Keyword MajorTopicYN="N">Quadrivalent</Keyword><Keyword MajorTopicYN="N">Safety</Keyword><Keyword MajorTopicYN="N">Trivalent</Keyword><Keyword MajorTopicYN="N">Vaccine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>09</Month><Day>24</Day></PubMedPubDate><PubMedPubDate 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