Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50years of age: Results from a phase III, randomized, non-inferiority trial.
Identifieur interne : 000018 ( Main/Exploration ); précédent : 000017; suivant : 000019Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50years of age: Results from a phase III, randomized, non-inferiority trial.
Auteurs : Opokua Ofori-Anyinam [Belgique] ; Geert Leroux-Roels [Belgique] ; Mamadou Drame [États-Unis] ; Annelies Aerssens [Belgique] ; Cathy Maes [Belgique] ; Arshad Amanullah [États-Unis] ; Anne Schuind [États-Unis] ; Ping Li [États-Unis] ; Varsha K. Jain [États-Unis] ; Bruce L. Innis [États-Unis]Source :
- Vaccine [ 1873-2518 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Anticorps antibactériens (sang), Anticorps antiviraux (sang), Belgique, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, France, Humains, Mâle, Méthode en simple aveugle, Placebo (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Test ELISA, Tests d'inhibition de l'hémagglutination, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins antipneumococciques (administration et posologie), Vaccins antipneumococciques (effets indésirables), Vaccins antipneumococciques (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (immunologie).
- MESH :
- administration et posologie : Placebo, Vaccins antigrippaux, Vaccins antipneumococciques, Vaccins inactivés.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccins antigrippaux, Vaccins antipneumococciques.
- immunologie : Vaccins antigrippaux, Vaccins antipneumococciques, Vaccins inactivés.
- sang : Anticorps antibactériens, Anticorps antiviraux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adulte d'âge moyen, Belgique, Femelle, France, Humains, Mâle, Méthode en simple aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Test ELISA, Tests d'inhibition de l'hémagglutination.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Antibodies, Bacterial (blood), Antibodies, Viral (blood), Belgium, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Enzyme-Linked Immunosorbent Assay, Female, France, Hemagglutination Inhibition Tests, Humans, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Male, Middle Aged, Placebos (administration & dosage), Pneumococcal Vaccines (administration & dosage), Pneumococcal Vaccines (adverse effects), Pneumococcal Vaccines (immunology), Single-Blind Method, Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Placebos, Pneumococcal Vaccines, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Pneumococcal Vaccines.
- chemical , blood : Antibodies, Bacterial, Antibodies, Viral.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- chemical , immunology : Influenza Vaccines, Pneumococcal Vaccines, Vaccines, Inactivated.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Aged, Aged, 80 and over, Belgium, Enzyme-Linked Immunosorbent Assay, Female, France, Hemagglutination Inhibition Tests, Humans, Male, Middle Aged, Single-Blind Method.
Abstract
INTRODUCTION
We compared co-administration versus separate administration of an inactivated quadrivalent influenza vaccine (IIV4) with a 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults at high risk of complications of influenza and pneumococcal infection.
METHODS
This phase III, placebo-controlled, observer-blind trial (NCT02218697) was conducted in France and Belgium during the 2014-2015 influenza season. Adults≥50years of age meeting their country's vaccination recommendations were randomized 1:1 to co-administration or separate administration. Immunogenicity was assessed by hemagglutination inhibition (HI) titers for IIV4 and 22F-inhibition ELISA for PPV23. Co-primary objectives were to demonstrate non-inferiority of co-administration versus separate administration in terms of geometric mean titer (GMT) ratio for each influenza strain in the IIV4 and geometric mean concentration (GMC) ratio for six pneumococcal serotypes (1, 3, 4, 7F, 14, 19A) in the PPV23 in the per-protocol cohort (N=334).
RESULTS
The study met its co-primary objectives, with the upper limit of the 95% confidence interval of the GMT and GMC ratios (separate administration over co-administration) being ≤2.0 for all four antigens of the IIV4 and the six pre-selected serotypes of the PPV23, respectively. Immunogenicity of the IIV4 and PPV23 was similar regardless of administration schedule. In a post hoc analysis pooling participants ≥60years of age from the co-administration and separate administration groups, IIV4 immunogenicity was similar in higher risk adults with comorbidities (diabetes; respiratory, heart, kidney, liver, or neurological diseases; morbid obesity) versus those without. Both vaccines had an acceptable safety and reactogenicity profile; pain was the most common symptom, occurring more often with co-administration than separate administration.
CONCLUSION
The IIV4 and PPV23 can be co-administered without reducing antibody responses reflecting protection against influenza or pneumococcal disease. Co-administration of PPV23 at the annual influenza vaccination visit may improve uptake. Comorbidities had no impact on IIV4 immunogenicity, supporting its value in older adults with chronic medical conditions. Clinical Trial Registry Number: NCT02218697.
DOI: 10.1016/j.vaccine.2017.09.012
PubMed: 28987445
Affiliations:
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Electronic address: opokua.ofori-anyinam@gsk.com.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK, Wavre</wicri:regionArea><wicri:noRegion>Wavre</wicri:noRegion></affiliation></author><author><name sortKey="Leroux Roels, Geert" sort="Leroux Roels, Geert" uniqKey="Leroux Roels G" first="Geert" last="Leroux-Roels">Geert Leroux-Roels</name><affiliation wicri:level="1"><nlm:affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: geert.lerouxroels@ugent.be.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Drame, Mamadou" sort="Drame, Mamadou" uniqKey="Drame M" first="Mamadou" last="Drame">Mamadou Drame</name><affiliation wicri:level="2"><nlm:affiliation>GSK, Rockville, MD, United States. Electronic address: Mamadou.X.Drame@gsk.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, Rockville, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Aerssens, Annelies" sort="Aerssens, Annelies" uniqKey="Aerssens A" first="Annelies" last="Aerssens">Annelies Aerssens</name><affiliation wicri:level="1"><nlm:affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: annelies.aerssens@uzgent.be.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Maes, Cathy" sort="Maes, Cathy" uniqKey="Maes C" first="Cathy" last="Maes">Cathy Maes</name><affiliation wicri:level="1"><nlm:affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: Cathy.Maes@uzgent.be.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Amanullah, Arshad" sort="Amanullah, Arshad" uniqKey="Amanullah A" first="Arshad" last="Amanullah">Arshad Amanullah</name><affiliation wicri:level="2"><nlm:affiliation>GSK, Rockville, MD, United States. Electronic address: Arshad.A.Amanullah@gsk.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, Rockville, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Schuind, Anne" sort="Schuind, Anne" uniqKey="Schuind A" first="Anne" last="Schuind">Anne Schuind</name><affiliation wicri:level="2"><nlm:affiliation>GSK, Rockville, MD, United States. Electronic address: Anne.E.Schuind@gsk.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, Rockville, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></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>GSK, King of Prussia, PA, United States. Electronic address: pingli.rtp@hotmail.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, King of Prussia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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>GSK, King of Prussia, PA, United States. Electronic address: Varshakjain@gmail.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, King of Prussia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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>GSK, King of Prussia, PA, United States. Electronic address: innisb00@gmail.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GSK, King of Prussia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Antibodies, Bacterial (blood)</term><term>Antibodies, Viral (blood)</term><term>Belgium</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>France</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>Male</term><term>Middle Aged</term><term>Placebos (administration & dosage)</term><term>Pneumococcal Vaccines (administration & dosage)</term><term>Pneumococcal Vaccines (adverse effects)</term><term>Pneumococcal Vaccines (immunology)</term><term>Single-Blind Method</term><term>Vaccines, Inactivated (administration & dosage)</term><term>Vaccines, Inactivated (immunology)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Anticorps antibactériens (sang)</term><term>Anticorps antiviraux (sang)</term><term>Belgique</term><term>Effets secondaires indésirables des médicaments (anatomopathologie)</term><term>Effets secondaires indésirables des médicaments (épidémiologie)</term><term>Femelle</term><term>France</term><term>Humains</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Placebo (administration et posologie)</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Test ELISA</term><term>Tests d'inhibition de l'hémagglutination</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins antipneumococciques (administration et posologie)</term><term>Vaccins antipneumococciques (effets indésirables)</term><term>Vaccins antipneumococciques (immunologie)</term><term>Vaccins inactivés (administration et posologie)</term><term>Vaccins inactivés (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term><term>Placebos</term><term>Pneumococcal Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term><term>Pneumococcal Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Bacterial</term><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Placebo</term><term>Vaccins antigrippaux</term><term>Vaccins antipneumococciques</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins antipneumococciques</term></keywords><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>Vaccins antigrippaux</term><term>Vaccins antipneumococciques</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Influenza Vaccines</term><term>Pneumococcal 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="sang" xml:lang="fr"><term>Anticorps antibactériens</term><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>Aged</term><term>Aged, 80 and over</term><term>Belgium</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>France</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Belgique</term><term>Femelle</term><term>France</term><term>Humains</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Test ELISA</term><term>Tests d'inhibition de l'hémagglutination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b></p><p>We compared co-administration versus separate administration of an inactivated quadrivalent influenza vaccine (IIV4) with a 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults at high risk of complications of influenza and pneumococcal infection.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>This phase III, placebo-controlled, observer-blind trial (NCT02218697) was conducted in France and Belgium during the 2014-2015 influenza season. Adults≥50years of age meeting their country's vaccination recommendations were randomized 1:1 to co-administration or separate administration. Immunogenicity was assessed by hemagglutination inhibition (HI) titers for IIV4 and 22F-inhibition ELISA for PPV23. Co-primary objectives were to demonstrate non-inferiority of co-administration versus separate administration in terms of geometric mean titer (GMT) ratio for each influenza strain in the IIV4 and geometric mean concentration (GMC) ratio for six pneumococcal serotypes (1, 3, 4, 7F, 14, 19A) in the PPV23 in the per-protocol cohort (N=334).</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>The study met its co-primary objectives, with the upper limit of the 95% confidence interval of the GMT and GMC ratios (separate administration over co-administration) being ≤2.0 for all four antigens of the IIV4 and the six pre-selected serotypes of the PPV23, respectively. Immunogenicity of the IIV4 and PPV23 was similar regardless of administration schedule. In a post hoc analysis pooling participants ≥60years of age from the co-administration and separate administration groups, IIV4 immunogenicity was similar in higher risk adults with comorbidities (diabetes; respiratory, heart, kidney, liver, or neurological diseases; morbid obesity) versus those without. Both vaccines had an acceptable safety and reactogenicity profile; pain was the most common symptom, occurring more often with co-administration than separate administration.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>The IIV4 and PPV23 can be co-administered without reducing antibody responses reflecting protection against influenza or pneumococcal disease. Co-administration of PPV23 at the annual influenza vaccination visit may improve uptake. Comorbidities had no impact on IIV4 immunogenicity, supporting its value in older adults with chronic medical conditions. Clinical Trial Registry Number: NCT02218697.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28987445</PMID><DateCompleted><Year>2018</Year><Month>05</Month><Day>29</Day></DateCompleted><DateRevised><Year>2018</Year><Month>05</Month><Day>29</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>35</Volume><Issue>46</Issue><PubDate><Year>2017</Year><Month>11</Month><Day>01</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50years of age: Results from a phase III, randomized, non-inferiority trial.</ArticleTitle><Pagination><MedlinePgn>6321-6328</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(17)31228-8</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2017.09.012</ELocationID><Abstract><AbstractText Label="INTRODUCTION">We compared co-administration versus separate administration of an inactivated quadrivalent influenza vaccine (IIV4) with a 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults at high risk of complications of influenza and pneumococcal infection.</AbstractText><AbstractText Label="METHODS">This phase III, placebo-controlled, observer-blind trial (NCT02218697) was conducted in France and Belgium during the 2014-2015 influenza season. Adults≥50years of age meeting their country's vaccination recommendations were randomized 1:1 to co-administration or separate administration. Immunogenicity was assessed by hemagglutination inhibition (HI) titers for IIV4 and 22F-inhibition ELISA for PPV23. Co-primary objectives were to demonstrate non-inferiority of co-administration versus separate administration in terms of geometric mean titer (GMT) ratio for each influenza strain in the IIV4 and geometric mean concentration (GMC) ratio for six pneumococcal serotypes (1, 3, 4, 7F, 14, 19A) in the PPV23 in the per-protocol cohort (N=334).</AbstractText><AbstractText Label="RESULTS">The study met its co-primary objectives, with the upper limit of the 95% confidence interval of the GMT and GMC ratios (separate administration over co-administration) being ≤2.0 for all four antigens of the IIV4 and the six pre-selected serotypes of the PPV23, respectively. Immunogenicity of the IIV4 and PPV23 was similar regardless of administration schedule. In a post hoc analysis pooling participants ≥60years of age from the co-administration and separate administration groups, IIV4 immunogenicity was similar in higher risk adults with comorbidities (diabetes; respiratory, heart, kidney, liver, or neurological diseases; morbid obesity) versus those without. Both vaccines had an acceptable safety and reactogenicity profile; pain was the most common symptom, occurring more often with co-administration than separate administration.</AbstractText><AbstractText Label="CONCLUSION">The IIV4 and PPV23 can be co-administered without reducing antibody responses reflecting protection against influenza or pneumococcal disease. Co-administration of PPV23 at the annual influenza vaccination visit may improve uptake. Comorbidities had no impact on IIV4 immunogenicity, supporting its value in older adults with chronic medical conditions. Clinical Trial Registry Number: NCT02218697.</AbstractText><CopyrightInformation>Copyright © 2017 GlaxoSmithKline SA. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ofori-Anyinam</LastName><ForeName>Opokua</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>GSK, Wavre, Belgium. Electronic address: opokua.ofori-anyinam@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leroux-Roels</LastName><ForeName>Geert</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: geert.lerouxroels@ugent.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Drame</LastName><ForeName>Mamadou</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>GSK, Rockville, MD, United States. Electronic address: Mamadou.X.Drame@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aerssens</LastName><ForeName>Annelies</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: annelies.aerssens@uzgent.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maes</LastName><ForeName>Cathy</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium. Electronic address: Cathy.Maes@uzgent.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Amanullah</LastName><ForeName>Arshad</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>GSK, Rockville, MD, United States. Electronic address: Arshad.A.Amanullah@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schuind</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>GSK, Rockville, MD, United States. Electronic address: Anne.E.Schuind@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Ping</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>GSK, King of Prussia, PA, United States. Electronic address: pingli.rtp@hotmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jain</LastName><ForeName>Varsha K</ForeName><Initials>VK</Initials><AffiliationInfo><Affiliation>GSK, King of Prussia, PA, United States. Electronic address: Varshakjain@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Innis</LastName><ForeName>Bruce L</ForeName><Initials>BL</Initials><AffiliationInfo><Affiliation>GSK, King of Prussia, PA, United States. Electronic address: innisb00@gmail.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02218697</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D000073843">Equivalence Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>10</Month><Day>05</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="C414006">23-valent pneumococcal capsular polysaccharide vaccine</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000907">Antibodies, Bacterial</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D022242">Pneumococcal Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000907" MajorTopicYN="N">Antibodies, Bacterial</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001530" MajorTopicYN="N">Belgium</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="D004797" MajorTopicYN="N">Enzyme-Linked Immunosorbent Assay</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005602" MajorTopicYN="N">France</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="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D022242" MajorTopicYN="N">Pneumococcal Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016037" MajorTopicYN="N">Single-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Co-administration</Keyword><Keyword MajorTopicYN="Y">Comorbidity</Keyword><Keyword MajorTopicYN="Y">Influenza</Keyword><Keyword MajorTopicYN="Y">Non-inferiority</Keyword><Keyword MajorTopicYN="Y">Pneumococcal</Keyword><Keyword MajorTopicYN="Y">Vaccine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>07</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>09</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>10</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>5</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>10</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28987445</ArticleId><ArticleId IdType="pii">S0264-410X(17)31228-8</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2017.09.012</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Belgique</li><li>États-Unis</li></country><region><li>Maryland</li><li>Pennsylvanie</li></region></list><tree><country name="Belgique"><noRegion><name sortKey="Ofori Anyinam, Opokua" sort="Ofori Anyinam, Opokua" uniqKey="Ofori Anyinam O" first="Opokua" last="Ofori-Anyinam">Opokua Ofori-Anyinam</name></noRegion><name sortKey="Aerssens, Annelies" sort="Aerssens, Annelies" uniqKey="Aerssens A" first="Annelies" last="Aerssens">Annelies Aerssens</name><name sortKey="Leroux Roels, Geert" sort="Leroux Roels, Geert" uniqKey="Leroux Roels G" first="Geert" last="Leroux-Roels">Geert Leroux-Roels</name><name sortKey="Maes, Cathy" sort="Maes, Cathy" uniqKey="Maes C" first="Cathy" last="Maes">Cathy Maes</name></country><country name="États-Unis"><region name="Maryland"><name sortKey="Drame, Mamadou" sort="Drame, Mamadou" uniqKey="Drame M" first="Mamadou" last="Drame">Mamadou Drame</name></region><name sortKey="Amanullah, Arshad" sort="Amanullah, Arshad" uniqKey="Amanullah A" first="Arshad" last="Amanullah">Arshad Amanullah</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="Schuind, Anne" sort="Schuind, Anne" uniqKey="Schuind A" first="Anne" last="Schuind">Anne Schuind</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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