Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.
Identifieur interne : 000218 ( Main/Exploration ); précédent : 000217; suivant : 000219Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.
Auteurs : Joanne M. Langley [Canada] ; Long Wang [États-Unis] ; Naresh Aggarwal [Canada] ; Agustin Bueso [Honduras] ; Vijayalakshmi Chandrasekaran [États-Unis] ; Luis Cousin [Honduras] ; Scott A. Halperin [Canada] ; Ping Li [États-Unis] ; Aixue Liu [États-Unis] ; Shelly Mcneil [Canada] ; Lourdes Pe A Mendez [République dominicaine] ; Luis Rivera [République dominicaine] ; Bruce L. Innis [États-Unis] ; Varsha K. Jain [États-Unis]Source :
- Journal of the Pediatric Infectious Diseases Society [ 2048-7207 ] ; 2015.
Descripteurs français
- KwdFr :
- Canada (MeSH), Enfant d'âge préscolaire (MeSH), Femelle (MeSH), Grippe humaine (immunologie), Grippe humaine (prévention et contrôle), Honduras (MeSH), Humains (MeSH), Immunogénicité des vaccins (MeSH), Injections musculaires (MeSH), Mâle (MeSH), Méthode en double aveugle (MeSH), Nourrisson (MeSH), République dominicaine (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets indésirables), Vaccins inactivés (immunologie), Virus influenza B (immunologie).
- MESH :
- administration et posologie : Vaccins antigrippaux, Vaccins inactivés.
- effets indésirables : Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Grippe humaine, Vaccins antigrippaux, Vaccins inactivés, Virus influenza B.
- prévention et contrôle : Grippe humaine.
- Canada, Enfant d'âge préscolaire, Femelle, Honduras, Humains, Immunogénicité des vaccins, Injections musculaires, Mâle, Méthode en double aveugle, Nourrisson, République dominicaine.
English descriptors
- KwdEn :
- Canada (MeSH), Child, Preschool (MeSH), Dominican Republic (MeSH), Double-Blind Method (MeSH), Female (MeSH), Honduras (MeSH), Humans (MeSH), Immunogenicity, Vaccine (MeSH), Infant (MeSH), Influenza B virus (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (immunology), Influenza, Human (prevention & control), Injections, Intramuscular (MeSH), Male (MeSH), Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- immunology : Influenza B virus, Influenza Vaccines, Influenza, Human, Vaccines, Inactivated.
- prevention & control : Influenza, Human.
- Canada, Child, Preschool, Dominican Republic, Double-Blind Method, Female, Honduras, Humans, Immunogenicity, Vaccine, Infant, Injections, Intramuscular, Male.
Abstract
BACKGROUND
Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.
METHODS
In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.
RESULTS
Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.
CONCLUSIONS
In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.
DOI: 10.1093/jpids/piu098
PubMed: 26336604
PubMed Central: PMC4554197
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.</title><author><name sortKey="Langley, Joanne M" sort="Langley, Joanne M" uniqKey="Langley J" first="Joanne M" last="Langley">Joanne M. Langley</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Long" sort="Wang, Long" uniqKey="Wang L" first="Long" last="Wang">Long Wang</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Aggarwal, Naresh" sort="Aggarwal, Naresh" uniqKey="Aggarwal N" first="Naresh" last="Aggarwal">Naresh Aggarwal</name><affiliation wicri:level="1"><nlm:affiliation>Aggarwal and Associates Limited, Brampton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Aggarwal and Associates Limited, Brampton, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bueso, Agustin" sort="Bueso, Agustin" uniqKey="Bueso A" first="Agustin" last="Bueso">Agustin Bueso</name><affiliation wicri:level="1"><nlm:affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</nlm:affiliation><country xml:lang="fr">Honduras</country><wicri:regionArea>Tecnologia en Investigacion, San Pedro Sula</wicri:regionArea><wicri:noRegion>San Pedro Sula</wicri:noRegion></affiliation></author><author><name sortKey="Chandrasekaran, Vijayalakshmi" sort="Chandrasekaran, Vijayalakshmi" uniqKey="Chandrasekaran V" first="Vijayalakshmi" last="Chandrasekaran">Vijayalakshmi Chandrasekaran</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Cousin, Luis" sort="Cousin, Luis" uniqKey="Cousin L" first="Luis" last="Cousin">Luis Cousin</name><affiliation wicri:level="1"><nlm:affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</nlm:affiliation><country xml:lang="fr">Honduras</country><wicri:regionArea>Tecnologia en Investigacion, San Pedro Sula</wicri:regionArea><wicri:noRegion>San Pedro Sula</wicri:noRegion></affiliation></author><author><name sortKey="Halperin, Scott A" sort="Halperin, Scott A" uniqKey="Halperin S" first="Scott A" last="Halperin">Scott A. Halperin</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Liu, Aixue" sort="Liu, Aixue" uniqKey="Liu A" first="Aixue" last="Liu">Aixue Liu</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Mcneil, Shelly" sort="Mcneil, Shelly" uniqKey="Mcneil S" first="Shelly" last="Mcneil">Shelly Mcneil</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Mendez, Lourdes Pe A" sort="Mendez, Lourdes Pe A" uniqKey="Mendez L" first="Lourdes Pe A" last="Mendez">Lourdes Pe A Mendez</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</nlm:affiliation><country xml:lang="fr">République dominicaine</country><wicri:regionArea>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo</wicri:regionArea><wicri:noRegion>Santo Domingo</wicri:noRegion></affiliation></author><author><name sortKey="Rivera, Luis" sort="Rivera, Luis" uniqKey="Rivera L" first="Luis" last="Rivera">Luis Rivera</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</nlm:affiliation><country xml:lang="fr">République dominicaine</country><wicri:regionArea>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo</wicri:regionArea><wicri:noRegion>Santo Domingo</wicri:noRegion></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L" last="Innis">Bruce L. Innis</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Jain, Varsha K" sort="Jain, Varsha K" uniqKey="Jain V" first="Varsha K" last="Jain">Varsha K. Jain</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26336604</idno><idno type="pmid">26336604</idno><idno type="doi">10.1093/jpids/piu098</idno><idno type="pmc">PMC4554197</idno><idno type="wicri:Area/Main/Corpus">000194</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000194</idno><idno type="wicri:Area/Main/Curation">000194</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000194</idno><idno type="wicri:Area/Main/Exploration">000194</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.</title><author><name sortKey="Langley, Joanne M" sort="Langley, Joanne M" uniqKey="Langley J" first="Joanne M" last="Langley">Joanne M. Langley</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Long" sort="Wang, Long" uniqKey="Wang L" first="Long" last="Wang">Long Wang</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Aggarwal, Naresh" sort="Aggarwal, Naresh" uniqKey="Aggarwal N" first="Naresh" last="Aggarwal">Naresh Aggarwal</name><affiliation wicri:level="1"><nlm:affiliation>Aggarwal and Associates Limited, Brampton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Aggarwal and Associates Limited, Brampton, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bueso, Agustin" sort="Bueso, Agustin" uniqKey="Bueso A" first="Agustin" last="Bueso">Agustin Bueso</name><affiliation wicri:level="1"><nlm:affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</nlm:affiliation><country xml:lang="fr">Honduras</country><wicri:regionArea>Tecnologia en Investigacion, San Pedro Sula</wicri:regionArea><wicri:noRegion>San Pedro Sula</wicri:noRegion></affiliation></author><author><name sortKey="Chandrasekaran, Vijayalakshmi" sort="Chandrasekaran, Vijayalakshmi" uniqKey="Chandrasekaran V" first="Vijayalakshmi" last="Chandrasekaran">Vijayalakshmi Chandrasekaran</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Cousin, Luis" sort="Cousin, Luis" uniqKey="Cousin L" first="Luis" last="Cousin">Luis Cousin</name><affiliation wicri:level="1"><nlm:affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</nlm:affiliation><country xml:lang="fr">Honduras</country><wicri:regionArea>Tecnologia en Investigacion, San Pedro Sula</wicri:regionArea><wicri:noRegion>San Pedro Sula</wicri:noRegion></affiliation></author><author><name sortKey="Halperin, Scott A" sort="Halperin, Scott A" uniqKey="Halperin S" first="Scott A" last="Halperin">Scott A. Halperin</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Liu, Aixue" sort="Liu, Aixue" uniqKey="Liu A" first="Aixue" last="Liu">Aixue Liu</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Mcneil, Shelly" sort="Mcneil, Shelly" uniqKey="Mcneil S" first="Shelly" last="Mcneil">Shelly Mcneil</name><affiliation wicri:level="1"><nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea><wicri:noRegion>Nova Scotia</wicri:noRegion></affiliation></author><author><name sortKey="Mendez, Lourdes Pe A" sort="Mendez, Lourdes Pe A" uniqKey="Mendez L" first="Lourdes Pe A" last="Mendez">Lourdes Pe A Mendez</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</nlm:affiliation><country xml:lang="fr">République dominicaine</country><wicri:regionArea>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo</wicri:regionArea><wicri:noRegion>Santo Domingo</wicri:noRegion></affiliation></author><author><name sortKey="Rivera, Luis" sort="Rivera, Luis" uniqKey="Rivera L" first="Luis" last="Rivera">Luis Rivera</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</nlm:affiliation><country xml:lang="fr">République dominicaine</country><wicri:regionArea>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo</wicri:regionArea><wicri:noRegion>Santo Domingo</wicri:noRegion></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L" last="Innis">Bruce L. Innis</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Jain, Varsha K" sort="Jain, Varsha K" uniqKey="Jain V" first="Varsha K" last="Jain">Varsha K. Jain</name><affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, King of Prussia</wicri:cityArea></affiliation></author></analytic><series><title level="j">Journal of the Pediatric Infectious Diseases Society</title><idno type="eISSN">2048-7207</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Canada (MeSH)</term><term>Child, Preschool (MeSH)</term><term>Dominican Republic (MeSH)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Honduras (MeSH)</term><term>Humans (MeSH)</term><term>Immunogenicity, Vaccine (MeSH)</term><term>Infant (MeSH)</term><term>Influenza B virus (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Injections, Intramuscular (MeSH)</term><term>Male (MeSH)</term><term>Vaccines, Inactivated (administration & dosage)</term><term>Vaccines, Inactivated (adverse effects)</term><term>Vaccines, Inactivated (immunology)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Canada (MeSH)</term><term>Enfant d'âge préscolaire (MeSH)</term><term>Femelle (MeSH)</term><term>Grippe humaine (immunologie)</term><term>Grippe humaine (prévention et contrôle)</term><term>Honduras (MeSH)</term><term>Humains (MeSH)</term><term>Immunogénicité des vaccins (MeSH)</term><term>Injections musculaires (MeSH)</term><term>Mâle (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Nourrisson (MeSH)</term><term>République dominicaine (MeSH)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins inactivés (administration et posologie)</term><term>Vaccins inactivés (effets indésirables)</term><term>Vaccins inactivés (immunologie)</term><term>Virus influenza B (immunologie)</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" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Grippe humaine</term><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term><term>Virus influenza B</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza B virus</term><term>Influenza Vaccines</term><term>Influenza, Human</term><term>Vaccines, Inactivated</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" xml:lang="en"><term>Canada</term><term>Child, Preschool</term><term>Dominican Republic</term><term>Double-Blind Method</term><term>Female</term><term>Honduras</term><term>Humans</term><term>Immunogenicity, Vaccine</term><term>Infant</term><term>Injections, Intramuscular</term><term>Male</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Canada</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Honduras</term><term>Humains</term><term>Immunogénicité des vaccins</term><term>Injections musculaires</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Nourrisson</term><term>République dominicaine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26336604</PMID><DateCompleted><Year>2017</Year><Month>08</Month><Day>21</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2048-7207</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>3</Issue><PubDate><Year>2015</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Journal of the Pediatric Infectious Diseases Society</Title><ISOAbbreviation>J Pediatric Infect Dis Soc</ISOAbbreviation></Journal><ArticleTitle>Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.</ArticleTitle><Pagination><MedlinePgn>242-51</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/jpids/piu098</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Langley</LastName><ForeName>Joanne M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Long</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aggarwal</LastName><ForeName>Naresh</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Aggarwal and Associates Limited, Brampton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bueso</LastName><ForeName>Agustin</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chandrasekaran</LastName><ForeName>Vijayalakshmi</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cousin</LastName><ForeName>Luis</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Tecnologia en Investigacion, San Pedro Sula, Honduras.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Halperin</LastName><ForeName>Scott A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Ping</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Aixue</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McNeil</LastName><ForeName>Shelly</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mendez</LastName><ForeName>Lourdes Peña</ForeName><Initials>LP</Initials><AffiliationInfo><Affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rivera</LastName><ForeName>Luis</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Hospital de Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Innis</LastName><ForeName>Bruce L</ForeName><Initials>BL</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jain</LastName><ForeName>Varsha K</ForeName><Initials>VK</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><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>2014</Year><Month>10</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Pediatric Infect Dis Soc</MedlineTA><NlmUniqueID>101586049</NlmUniqueID><ISSNLinking>2048-7193</ISSNLinking></MedlineJournalInfo><ChemicalList><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="D002170" MajorTopicYN="N">Canada</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004293" MajorTopicYN="N">Dominican Republic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006721" MajorTopicYN="N">Honduras</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000071497" MajorTopicYN="N">Immunogenicity, Vaccine</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009981" MajorTopicYN="Y">Influenza B virus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">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="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007273" MajorTopicYN="N">Injections, Intramuscular</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</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></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">children</Keyword><Keyword MajorTopicYN="N">immunogenicity</Keyword><Keyword MajorTopicYN="N">influenza vaccine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>03</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>09</Month><Day>02</Day></PubMedPubDate><PubMedPubDate 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Langley</name></noRegion><name sortKey="Aggarwal, Naresh" sort="Aggarwal, Naresh" uniqKey="Aggarwal N" first="Naresh" last="Aggarwal">Naresh Aggarwal</name><name sortKey="Halperin, Scott A" sort="Halperin, Scott A" uniqKey="Halperin S" first="Scott A" last="Halperin">Scott A. Halperin</name><name sortKey="Mcneil, Shelly" sort="Mcneil, Shelly" uniqKey="Mcneil S" first="Shelly" last="Mcneil">Shelly Mcneil</name></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Wang, Long" sort="Wang, Long" uniqKey="Wang L" first="Long" last="Wang">Long Wang</name></region><name sortKey="Chandrasekaran, Vijayalakshmi" sort="Chandrasekaran, Vijayalakshmi" uniqKey="Chandrasekaran V" first="Vijayalakshmi" last="Chandrasekaran">Vijayalakshmi Chandrasekaran</name><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L" last="Innis">Bruce L. Innis</name><name sortKey="Jain, Varsha K" sort="Jain, Varsha K" uniqKey="Jain V" first="Varsha K" last="Jain">Varsha K. Jain</name><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name><name sortKey="Liu, Aixue" sort="Liu, Aixue" uniqKey="Liu A" first="Aixue" last="Liu">Aixue Liu</name></country><country name="Honduras"><noRegion><name sortKey="Bueso, Agustin" sort="Bueso, Agustin" uniqKey="Bueso A" first="Agustin" last="Bueso">Agustin Bueso</name></noRegion><name sortKey="Cousin, Luis" sort="Cousin, Luis" uniqKey="Cousin L" first="Luis" last="Cousin">Luis Cousin</name></country><country name="République dominicaine"><noRegion><name sortKey="Mendez, Lourdes Pe A" sort="Mendez, Lourdes Pe A" uniqKey="Mendez L" first="Lourdes Pe A" last="Mendez">Lourdes Pe A Mendez</name></noRegion><name sortKey="Rivera, Luis" sort="Rivera, Luis" uniqKey="Rivera L" first="Luis" last="Rivera">Luis Rivera</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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