Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.
Identifieur interne : 000208 ( Main/Corpus ); précédent : 000207; suivant : 000209Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.
Auteurs : Ulrich Zimmermann ; Gaëtan Gavazzi ; Patrick Richard ; Cécile Eymin ; Benoît Soubeyrand ; Martine BaudinSource :
- Vaccine [ 1873-2518 ] ; 2013.
English descriptors
- KwdEn :
- Aged (MeSH), Antibodies, Bacterial (blood), Antibodies, Viral (blood), Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage), Diphtheria-Tetanus-Pertussis Vaccine (adverse effects), Diphtheria-Tetanus-Pertussis Vaccine (immunology), Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female (MeSH), France (MeSH), Germany (MeSH), Humans (MeSH), Immunization, Secondary (adverse effects), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Male (MeSH), Middle Aged (MeSH), Poliovirus Vaccine, Inactivated (administration & dosage), Poliovirus Vaccine, Inactivated (adverse effects), Poliovirus Vaccine, Inactivated (immunology), Vaccines, Combined (administration & dosage), Vaccines, Combined (adverse effects), Vaccines, Combined (immunology), Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Diphtheria-Tetanus-Pertussis Vaccine, Influenza Vaccines, Poliovirus Vaccine, Inactivated, Vaccines, Combined, Vaccines, Inactivated.
- chemical , adverse effects : Diphtheria-Tetanus-Pertussis Vaccine, Influenza Vaccines, Poliovirus Vaccine, Inactivated, Vaccines, Combined, Vaccines, Inactivated.
- chemical , blood : Antibodies, Bacterial, Antibodies, Viral.
- chemical , immunology : Diphtheria-Tetanus-Pertussis Vaccine, Influenza Vaccines, Poliovirus Vaccine, Inactivated, Vaccines, Combined, Vaccines, Inactivated.
- geographic : France, Germany.
- adverse effects : Immunization, Secondary.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Aged, Female, Humans, Male, Middle Aged.
Abstract
BACKGROUND
Annual influenza vaccination provides an opportunity to administer a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV) to the elderly. This study evaluated immune responses to and safety of the two vaccines administered concomitantly or sequentially to elderly individuals in France and Germany.
METHODS
Individuals aged ≥60 years who had received a diphtheria/tetanus booster within 5-15 years were randomised (1:1) to receive either Tdap-IPV and an inactivated influenza vaccine concomitantly (Group 1) or inactivated influenza vaccine then Tdap-IPV 28-35 days later (Group 2). Antibody titres were measured before and 28-35 days after each vaccination.
RESULTS
The mean age of randomised individuals (n=954) was 68.8 years. Post-vaccination seroprotection rates (≥0.1 IU/mL for diphtheria/tetanus and ≥8 1/dilution for polio) for Group 1 were non-inferior to Group 2 for diphtheria (85.4% vs. 87.5%), tetanus (both 100%), polio type 1 (99.8% vs. 100%), polio type 2 (both 100%) and polio type 3 (99.3% vs. 99.8%). Similarly, percentages of individuals with pertussis antibodies ≥5 EU/mL for Group 1 were non-inferior to Group 2: pertussis toxin (94.3% vs. 98.1%), filamentous haemagglutinin (99.8% vs. 100%), pertactin (97.3% vs. 96.0%), fimbriae 2 and 3 (91.7% vs. 89.5%). Post-vaccination geometric mean titres of anti-influenza haemagglutinin antibodies for Group 1 were non-inferior to Group 2. Adverse events following administration of Tdap-IPV were similar in both study groups, with no vaccine-related serious adverse events.
CONCLUSION
Tdap-IPV and inactivated influenza vaccine can be administered concomitantly in the elderly without impairing tolerability or the immune response to either vaccine.
DOI: 10.1016/j.vaccine.2012.12.081
PubMed: 23313654
Links to Exploration step
pubmed:23313654Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.</title>
<author><name sortKey="Zimmermann, Ulrich" sort="Zimmermann, Ulrich" uniqKey="Zimmermann U" first="Ulrich" last="Zimmermann">Ulrich Zimmermann</name>
<affiliation><nlm:affiliation>Internistische Gemeinschaftspraxis, Sülmerstraße 32, D74072, Heilbronn, Germany. Dr.UlrichZimmermann@web.de</nlm:affiliation>
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</author>
<author><name sortKey="Gavazzi, Gaetan" sort="Gavazzi, Gaetan" uniqKey="Gavazzi G" first="Gaëtan" last="Gavazzi">Gaëtan Gavazzi</name>
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<author><name sortKey="Richard, Patrick" sort="Richard, Patrick" uniqKey="Richard P" first="Patrick" last="Richard">Patrick Richard</name>
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<author><name sortKey="Eymin, Cecile" sort="Eymin, Cecile" uniqKey="Eymin C" first="Cécile" last="Eymin">Cécile Eymin</name>
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<author><name sortKey="Soubeyrand, Benoit" sort="Soubeyrand, Benoit" uniqKey="Soubeyrand B" first="Benoît" last="Soubeyrand">Benoît Soubeyrand</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.</title>
<author><name sortKey="Zimmermann, Ulrich" sort="Zimmermann, Ulrich" uniqKey="Zimmermann U" first="Ulrich" last="Zimmermann">Ulrich Zimmermann</name>
<affiliation><nlm:affiliation>Internistische Gemeinschaftspraxis, Sülmerstraße 32, D74072, Heilbronn, Germany. Dr.UlrichZimmermann@web.de</nlm:affiliation>
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<author><name sortKey="Gavazzi, Gaetan" sort="Gavazzi, Gaetan" uniqKey="Gavazzi G" first="Gaëtan" last="Gavazzi">Gaëtan Gavazzi</name>
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<author><name sortKey="Richard, Patrick" sort="Richard, Patrick" uniqKey="Richard P" first="Patrick" last="Richard">Patrick Richard</name>
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<author><name sortKey="Eymin, Cecile" sort="Eymin, Cecile" uniqKey="Eymin C" first="Cécile" last="Eymin">Cécile Eymin</name>
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<author><name sortKey="Soubeyrand, Benoit" sort="Soubeyrand, Benoit" uniqKey="Soubeyrand B" first="Benoît" last="Soubeyrand">Benoît Soubeyrand</name>
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<author><name sortKey="Baudin, Martine" sort="Baudin, Martine" uniqKey="Baudin M" first="Martine" last="Baudin">Martine Baudin</name>
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<series><title level="j">Vaccine</title>
<idno type="eISSN">1873-2518</idno>
<imprint><date when="2013" type="published">2013</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged (MeSH)</term>
<term>Antibodies, Bacterial (blood)</term>
<term>Antibodies, Viral (blood)</term>
<term>Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage)</term>
<term>Diphtheria-Tetanus-Pertussis Vaccine (adverse effects)</term>
<term>Diphtheria-Tetanus-Pertussis Vaccine (immunology)</term>
<term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term>
<term>Drug-Related Side Effects and Adverse Reactions (pathology)</term>
<term>Female (MeSH)</term>
<term>France (MeSH)</term>
<term>Germany (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Immunization, Secondary (adverse effects)</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza Vaccines (immunology)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Poliovirus Vaccine, Inactivated (administration & dosage)</term>
<term>Poliovirus Vaccine, Inactivated (adverse effects)</term>
<term>Poliovirus Vaccine, Inactivated (immunology)</term>
<term>Vaccines, Combined (administration & dosage)</term>
<term>Vaccines, Combined (adverse effects)</term>
<term>Vaccines, Combined (immunology)</term>
<term>Vaccines, Inactivated (administration & dosage)</term>
<term>Vaccines, Inactivated (adverse effects)</term>
<term>Vaccines, Inactivated (immunology)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term>
<term>Influenza Vaccines</term>
<term>Poliovirus Vaccine, Inactivated</term>
<term>Vaccines, Combined</term>
<term>Vaccines, Inactivated</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term>
<term>Influenza Vaccines</term>
<term>Poliovirus Vaccine, Inactivated</term>
<term>Vaccines, Combined</term>
<term>Vaccines, Inactivated</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Bacterial</term>
<term>Antibodies, Viral</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term>
<term>Influenza Vaccines</term>
<term>Poliovirus Vaccine, Inactivated</term>
<term>Vaccines, Combined</term>
<term>Vaccines, Inactivated</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term>
<term>Germany</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Immunization, Secondary</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" xml:lang="en"><term>Aged</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>Annual influenza vaccination provides an opportunity to administer a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV) to the elderly. This study evaluated immune responses to and safety of the two vaccines administered concomitantly or sequentially to elderly individuals in France and Germany.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>Individuals aged ≥60 years who had received a diphtheria/tetanus booster within 5-15 years were randomised (1:1) to receive either Tdap-IPV and an inactivated influenza vaccine concomitantly (Group 1) or inactivated influenza vaccine then Tdap-IPV 28-35 days later (Group 2). Antibody titres were measured before and 28-35 days after each vaccination.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>The mean age of randomised individuals (n=954) was 68.8 years. Post-vaccination seroprotection rates (≥0.1 IU/mL for diphtheria/tetanus and ≥8 1/dilution for polio) for Group 1 were non-inferior to Group 2 for diphtheria (85.4% vs. 87.5%), tetanus (both 100%), polio type 1 (99.8% vs. 100%), polio type 2 (both 100%) and polio type 3 (99.3% vs. 99.8%). Similarly, percentages of individuals with pertussis antibodies ≥5 EU/mL for Group 1 were non-inferior to Group 2: pertussis toxin (94.3% vs. 98.1%), filamentous haemagglutinin (99.8% vs. 100%), pertactin (97.3% vs. 96.0%), fimbriae 2 and 3 (91.7% vs. 89.5%). Post-vaccination geometric mean titres of anti-influenza haemagglutinin antibodies for Group 1 were non-inferior to Group 2. Adverse events following administration of Tdap-IPV were similar in both study groups, with no vaccine-related serious adverse events.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSION</b>
</p>
<p>Tdap-IPV and inactivated influenza vaccine can be administered concomitantly in the elderly without impairing tolerability or the immune response to either vaccine.</p>
</div>
</front>
</TEI>
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<DateCompleted><Year>2013</Year>
<Month>08</Month>
<Day>19</Day>
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<DateRevised><Year>2013</Year>
<Month>11</Month>
<Day>21</Day>
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<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>31</Volume>
<Issue>11</Issue>
<PubDate><Year>2013</Year>
<Month>Mar</Month>
<Day>01</Day>
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<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
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<ArticleTitle>Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.</ArticleTitle>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Annual influenza vaccination provides an opportunity to administer a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV) to the elderly. This study evaluated immune responses to and safety of the two vaccines administered concomitantly or sequentially to elderly individuals in France and Germany.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Individuals aged ≥60 years who had received a diphtheria/tetanus booster within 5-15 years were randomised (1:1) to receive either Tdap-IPV and an inactivated influenza vaccine concomitantly (Group 1) or inactivated influenza vaccine then Tdap-IPV 28-35 days later (Group 2). Antibody titres were measured before and 28-35 days after each vaccination.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The mean age of randomised individuals (n=954) was 68.8 years. Post-vaccination seroprotection rates (≥0.1 IU/mL for diphtheria/tetanus and ≥8 1/dilution for polio) for Group 1 were non-inferior to Group 2 for diphtheria (85.4% vs. 87.5%), tetanus (both 100%), polio type 1 (99.8% vs. 100%), polio type 2 (both 100%) and polio type 3 (99.3% vs. 99.8%). Similarly, percentages of individuals with pertussis antibodies ≥5 EU/mL for Group 1 were non-inferior to Group 2: pertussis toxin (94.3% vs. 98.1%), filamentous haemagglutinin (99.8% vs. 100%), pertactin (97.3% vs. 96.0%), fimbriae 2 and 3 (91.7% vs. 89.5%). Post-vaccination geometric mean titres of anti-influenza haemagglutinin antibodies for Group 1 were non-inferior to Group 2. Adverse events following administration of Tdap-IPV were similar in both study groups, with no vaccine-related serious adverse events.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Tdap-IPV and inactivated influenza vaccine can be administered concomitantly in the elderly without impairing tolerability or the immune response to either vaccine.</AbstractText>
<CopyrightInformation>Copyright © 2013 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Zimmermann</LastName>
<ForeName>Ulrich</ForeName>
<Initials>U</Initials>
<AffiliationInfo><Affiliation>Internistische Gemeinschaftspraxis, Sülmerstraße 32, D74072, Heilbronn, Germany. Dr.UlrichZimmermann@web.de</Affiliation>
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<Author ValidYN="Y"><LastName>Gavazzi</LastName>
<ForeName>Gaëtan</ForeName>
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<Author ValidYN="Y"><LastName>Richard</LastName>
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<Author ValidYN="Y"><LastName>Eymin</LastName>
<ForeName>Cécile</ForeName>
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<Author ValidYN="Y"><LastName>Soubeyrand</LastName>
<ForeName>Benoît</ForeName>
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<Author ValidYN="Y"><LastName>Baudin</LastName>
<ForeName>Martine</ForeName>
<Initials>M</Initials>
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<Language>eng</Language>
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<ArticleDate DateType="Electronic"><Year>2013</Year>
<Month>01</Month>
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<MedlineJournalInfo><Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
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<ISSNLinking>0264-410X</ISSNLinking>
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<NameOfSubstance UI="D000907">Antibodies, Bacterial</NameOfSubstance>
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<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance>
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<NameOfSubstance UI="C051021">DTPP vaccine</NameOfSubstance>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
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