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Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries

In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX(®)) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur(®...

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Autores principales: Laurichesse, Henri, Zimmermann, Ulrich, Galtier, Florence, Launay, Odile, Duval, Xavier, Richard, Patrick, Sadorge, Christine, Soubeyrand, Benoit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Landes Bioscience 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3656080/
https://www.ncbi.nlm.nih.gov/pubmed/23032160
http://dx.doi.org/10.4161/hv.22083
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author Laurichesse, Henri
Zimmermann, Ulrich
Galtier, Florence
Launay, Odile
Duval, Xavier
Richard, Patrick
Sadorge, Christine
Soubeyrand, Benoit
author_facet Laurichesse, Henri
Zimmermann, Ulrich
Galtier, Florence
Launay, Odile
Duval, Xavier
Richard, Patrick
Sadorge, Christine
Soubeyrand, Benoit
author_sort Laurichesse, Henri
collection PubMed
description In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX(®)) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur(®) or Tetavax(®)) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5−10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28. Outcomes: per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: –1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed. ClinicalTrials.gov identifier: NCT00928785. Research sponsored by Sanofi Pasteur MSD.
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spelling pubmed-36560802013-05-23 Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries Laurichesse, Henri Zimmermann, Ulrich Galtier, Florence Launay, Odile Duval, Xavier Richard, Patrick Sadorge, Christine Soubeyrand, Benoit Hum Vaccin Immunother Research Paper In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX(®)) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur(®) or Tetavax(®)) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5−10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28. Outcomes: per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: –1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed. ClinicalTrials.gov identifier: NCT00928785. Research sponsored by Sanofi Pasteur MSD. Landes Bioscience 2012-12-01 2012-10-02 /pmc/articles/PMC3656080/ /pubmed/23032160 http://dx.doi.org/10.4161/hv.22083 Text en Copyright © 2012 Landes Bioscience http://creativecommons.org/licenses/by-nc/3.0/ This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.
spellingShingle Research Paper
Laurichesse, Henri
Zimmermann, Ulrich
Galtier, Florence
Launay, Odile
Duval, Xavier
Richard, Patrick
Sadorge, Christine
Soubeyrand, Benoit
Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title_full Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title_fullStr Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title_full_unstemmed Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title_short Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(®)) and a tetanus monovalent vaccine in healthy adults: New considerations for the management of patients with tetanus-prone injuries
title_sort immunogenicity and safety results from a randomized multicenter trial comparing a tdap-ipv vaccine (repevax(®)) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3656080/
https://www.ncbi.nlm.nih.gov/pubmed/23032160
http://dx.doi.org/10.4161/hv.22083
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