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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 : 000210 ( Main/Exploration ); précédent : 000209; suivant : 000211

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.

Auteurs : Ulrich Zimmermann [Allemagne] ; Gaëtan Gavazzi ; Patrick Richard ; Cécile Eymin ; Benoît Soubeyrand ; Martine Baudin

Source :

RBID : pubmed:23313654

Descripteurs français

English descriptors

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


Affiliations:


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Le document en format XML

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<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>
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<term>Adulte d'âge moyen (MeSH)</term>
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<term>Anticorps antiviraux (sang)</term>
<term>Effets secondaires indésirables des médicaments (anatomopathologie)</term>
<term>Effets secondaires indésirables des médicaments (épidémiologie)</term>
<term>Femelle (MeSH)</term>
<term>France (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Rappel de vaccin (effets indésirables)</term>
<term>Sujet âgé (MeSH)</term>
<term>Vaccin antipoliomyélitique inactivé (administration et posologie)</term>
<term>Vaccin antipoliomyélitique inactivé (effets indésirables)</term>
<term>Vaccin antipoliomyélitique inactivé (immunologie)</term>
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<term>Vaccin diphtérie-tétanos-coqueluche (effets indésirables)</term>
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<term>Vaccins antigrippaux (effets indésirables)</term>
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<term>Vaccins combinés (administration et posologie)</term>
<term>Vaccins combinés (effets indésirables)</term>
<term>Vaccins combinés (immunologie)</term>
<term>Vaccins inactivés (administration et posologie)</term>
<term>Vaccins inactivés (effets indésirables)</term>
<term>Vaccins inactivés (immunologie)</term>
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<term>Vaccines, Inactivated</term>
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<term>Influenza Vaccines</term>
<term>Poliovirus Vaccine, Inactivated</term>
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<term>Vaccines, Inactivated</term>
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<term>Vaccines, Inactivated</term>
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<term>Vaccin antipoliomyélitique inactivé</term>
<term>Vaccin diphtérie-tétanos-coqueluche</term>
<term>Vaccins antigrippaux</term>
<term>Vaccins combinés</term>
<term>Vaccins inactivés</term>
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<term>Effets secondaires indésirables des médicaments</term>
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<term>Vaccin antipoliomyélitique inactivé</term>
<term>Vaccin diphtérie-tétanos-coqueluche</term>
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<b>BACKGROUND</b>
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<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>
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<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>
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<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>
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<Month>08</Month>
<Day>19</Day>
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<Year>2013</Year>
<Month>11</Month>
<Day>21</Day>
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<ISSN IssnType="Electronic">1873-2518</ISSN>
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<Volume>31</Volume>
<Issue>11</Issue>
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<Year>2013</Year>
<Month>Mar</Month>
<Day>01</Day>
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<Title>Vaccine</Title>
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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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<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>
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<CopyrightInformation>Copyright © 2013 Elsevier Ltd. All rights reserved.</CopyrightInformation>
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<Month>01</Month>
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<PubMedPubDate PubStatus="revised">
<Year>2012</Year>
<Month>12</Month>
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<PubMedPubDate PubStatus="accepted">
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<name sortKey="Baudin, Martine" sort="Baudin, Martine" uniqKey="Baudin M" first="Martine" last="Baudin">Martine Baudin</name>
<name sortKey="Eymin, Cecile" sort="Eymin, Cecile" uniqKey="Eymin C" first="Cécile" last="Eymin">Cécile Eymin</name>
<name sortKey="Gavazzi, Gaetan" sort="Gavazzi, Gaetan" uniqKey="Gavazzi G" first="Gaëtan" last="Gavazzi">Gaëtan Gavazzi</name>
<name sortKey="Richard, Patrick" sort="Richard, Patrick" uniqKey="Richard P" first="Patrick" last="Richard">Patrick Richard</name>
<name sortKey="Soubeyrand, Benoit" sort="Soubeyrand, Benoit" uniqKey="Soubeyrand B" first="Benoît" last="Soubeyrand">Benoît Soubeyrand</name>
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<country name="Allemagne">
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<name sortKey="Zimmermann, Ulrich" sort="Zimmermann, Ulrich" uniqKey="Zimmermann U" first="Ulrich" last="Zimmermann">Ulrich Zimmermann</name>
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</country>
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   |texte=   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.
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