Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2–10-year-old children: results of an open, randomised, controlled study
Identifieur interne : 000509 ( Main/Exploration ); précédent : 000508; suivant : 000510Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2–10-year-old children: results of an open, randomised, controlled study
Auteurs : Markus Knuf [Allemagne] ; Olivier Romain [France] ; Klaus Kindler [Allemagne] ; Uta Walther [Allemagne] ; Phu-My Tran [France] ; Heidemarie Pankow-Culot [Allemagne] ; Thomas Fischbach [Allemagne] ; Dorothee Kieninger-Baum [Allemagne] ; Véronique Bianco [Belgique] ; Yaela Baine [États-Unis] ; Jacqueline Miller [États-Unis]Source :
- European Journal of Pediatrics [ 0340-6199 ] ; 2013.
Abstract
In Europe, the introduction of monovalent meningococcal serogroup C (MenC) conjugate vaccines has resulted in a significant decline in MenC invasive disease. However, given the potential for strain evolution and increasing travel to areas of high endemicity, protection against additional serogroups is needed. In this study, the immunogenicity, measured by a serum bactericidal activity assay using rabbit complement (rSBA), and the safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) were compared to that of a licensed monovalent MenC conjugate vaccine (MenC-CRM197) in children 2–10 years of age. Children were randomised (3:1) to receive a single dose of either MenACWY-TT or MenC-CRM197. Non-inferiority of the immunogenicity of MenACWY-TT versus MenC-CRM197 in terms of rSBA-MenC vaccine response was demonstrated. Exploratory analyses suggested that rSBA-MenC geometric mean titres adjusted for pre-vaccination titres were lower in children vaccinated with MenACWY-TT compared to MenC-CRM197. Nevertheless, at 1 month post-vaccination, ≥99.3 % of the children who received MenACWY-TT had rSBA titres ≥1:128 for each of the four vaccine serogroups, which is the more conservative correlate of protection. The reactogenicity and safety profile of MenACWY-TT was clinically acceptable and no serious adverse events considered related to vaccination were reported throughout the study.
Url:
DOI: 10.1007/s00431-012-1924-0
PubMed: 23307281
PubMed Central: 3631514
Affiliations:
- Allemagne, Belgique, France, États-Unis
- Berlin, Pennsylvanie, Provence-Alpes-Côte d'Azur, Rhénanie-Palatinat, Vienne (Autriche), Île-de-France
- Berlin, Clamart, Mayence, Nice, Vienne (Autriche)
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type="wicri:Area/Main/Exploration">000509</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2–10-year-old children: results of an open, randomised, controlled study</title><author><name sortKey="Knuf, Markus" sort="Knuf, Markus" uniqKey="Knuf M" first="Markus" last="Knuf">Markus Knuf</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Childrens Hospital, Dr. Horst Schmidt Clinic, Ludwig-Erhard-Straße 100, 65199 Wiesbaden, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Childrens Hospital, Dr. Horst Schmidt Clinic, Ludwig-Erhard-Straße 100, 65199 Wiesbaden</wicri:regionArea><wicri:noRegion>65199 Wiesbaden</wicri:noRegion><wicri:noRegion>65199 Wiesbaden</wicri:noRegion><wicri:noRegion>65199 Wiesbaden</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff2">Department of Pediatrics, Johannes Gutenberg-University, Langenbeckstraße 1, 55131 Mainz, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Pediatrics, Johannes Gutenberg-University, Langenbeckstraße 1, 55131 Mainz</wicri:regionArea><placeName><region type="land" nuts="2">Rhénanie-Palatinat</region><settlement type="city">Mayence</settlement></placeName></affiliation></author><author><name sortKey="Romain, Olivier" sort="Romain, Olivier" uniqKey="Romain O" first="Olivier" last="Romain">Olivier Romain</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Service de Pédiatrie et de Réanimation Néonatale, Hôpital Antoine Béclère, 92140 Clamart, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service de Pédiatrie et de Réanimation Néonatale, Hôpital Antoine Béclère, 92140 Clamart</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Clamart</settlement></placeName></affiliation></author><author><name sortKey="Kindler, Klaus" sort="Kindler, Klaus" uniqKey="Kindler K" first="Klaus" last="Kindler">Klaus Kindler</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Töpferstraße 29, 54290 Trier, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Töpferstraße 29, 54290 Trier</wicri:regionArea><wicri:noRegion>54290 Trier</wicri:noRegion><wicri:noRegion>54290 Trier</wicri:noRegion><wicri:noRegion>54290 Trier</wicri:noRegion></affiliation></author><author><name sortKey="Walther, Uta" sort="Walther, Uta" uniqKey="Walther U" first="Uta" last="Walther">Uta Walther</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Reichenberger Straße 3, 13055 Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Reichenberger Straße 3, 13055 Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Tran, Phu My" sort="Tran, Phu My" uniqKey="Tran P" first="Phu-My" last="Tran">Phu-My Tran</name><affiliation wicri:level="3"><nlm:aff id="Aff6">Avenue de la République 37, 06300 Nice, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Avenue de la République 37, 06300 Nice</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Pankow Culot, Heidemarie" sort="Pankow Culot, Heidemarie" uniqKey="Pankow Culot H" first="Heidemarie" last="Pankow-Culot">Heidemarie Pankow-Culot</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Hauptstraße 165, 42579 Heiligenhaus, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Hauptstraße 165, 42579 Heiligenhaus</wicri:regionArea><wicri:noRegion>42579 Heiligenhaus</wicri:noRegion><wicri:noRegion>42579 Heiligenhaus</wicri:noRegion><wicri:noRegion>42579 Heiligenhaus</wicri:noRegion></affiliation></author><author><name sortKey="Fischbach, Thomas" sort="Fischbach, Thomas" uniqKey="Fischbach T" first="Thomas" last="Fischbach">Thomas Fischbach</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Focher Straße 20, 42719 Solingen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Focher Straße 20, 42719 Solingen</wicri:regionArea><wicri:noRegion>42719 Solingen</wicri:noRegion><wicri:noRegion>42719 Solingen</wicri:noRegion><wicri:noRegion>42719 Solingen</wicri:noRegion></affiliation></author><author><name sortKey="Kieninger Baum, Dorothee" sort="Kieninger Baum, Dorothee" uniqKey="Kieninger Baum D" first="Dorothee" last="Kieninger-Baum">Dorothee Kieninger-Baum</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Universitätsmedizin, Johannes Gutenber Universität, Zentrum für Kinder- und Jugendmedizin, Langenbeckstraße 1, 55101 Mainz, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Universitätsmedizin, Johannes Gutenber Universität, Zentrum für Kinder- und Jugendmedizin, Langenbeckstraße 1, 55101 Mainz</wicri:regionArea><wicri:noRegion>55101 Mainz</wicri:noRegion><wicri:noRegion>55101 Mainz</wicri:noRegion><wicri:noRegion>55101 Mainz</wicri:noRegion></affiliation></author><author><name sortKey="Bianco, Veronique" sort="Bianco, Veronique" uniqKey="Bianco V" first="Véronique" last="Bianco">Véronique Bianco</name><affiliation wicri:level="3"><nlm:aff id="Aff10">GlaxoSmithKline Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>GlaxoSmithKline Vaccines, Avenue Fleming 20, 1300 Wavre</wicri:regionArea><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></affiliation></author><author><name sortKey="Baine, Yaela" sort="Baine, Yaela" uniqKey="Baine Y" first="Yaela" last="Baine">Yaela Baine</name><affiliation wicri:level="2"><nlm:aff id="Aff11">GlaxoSmithKline Vaccines, Renaissance Boulevard 2301, King of Prussia, PA 19406 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, Renaissance Boulevard 2301, King of Prussia</wicri:cityArea></affiliation></author><author><name sortKey="Miller, Jacqueline" sort="Miller, Jacqueline" uniqKey="Miller J" first="Jacqueline" last="Miller">Jacqueline Miller</name><affiliation wicri:level="2"><nlm:aff id="Aff11">GlaxoSmithKline Vaccines, Renaissance Boulevard 2301, King of Prussia, PA 19406 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>GlaxoSmithKline Vaccines, Renaissance Boulevard 2301, King of Prussia</wicri:cityArea></affiliation></author></analytic><series><title level="j">European Journal of Pediatrics</title><idno type="ISSN">0340-6199</idno><idno type="eISSN">1432-1076</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>In Europe, the introduction of monovalent meningococcal serogroup C (MenC) conjugate vaccines has resulted in a significant decline in MenC invasive disease. However, given the potential for strain evolution and increasing travel to areas of high endemicity, protection against additional serogroups is needed. In this study, the immunogenicity, measured by a serum bactericidal activity assay using rabbit complement (rSBA), and the safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) were compared to that of a licensed monovalent MenC conjugate vaccine (MenC-CRM<sub>197</sub>) in children 2–10 years of age. Children were randomised (3:1) to receive a single dose of either MenACWY-TT or MenC-CRM<sub>197</sub>. Non-inferiority of the immunogenicity of MenACWY-TT versus MenC-CRM<sub>197</sub> in terms of rSBA-MenC vaccine response was demonstrated. Exploratory analyses suggested that rSBA-MenC geometric mean titres adjusted for pre-vaccination titres were lower in children vaccinated with MenACWY-TT compared to MenC-CRM<sub>197</sub>. Nevertheless, at 1 month post-vaccination, ≥99.3 % of the children who received MenACWY-TT had rSBA titres ≥1:128 for each of the four vaccine serogroups, which is the more conservative correlate of protection. The reactogenicity and safety profile of MenACWY-TT was clinically acceptable and no serious adverse events considered related to vaccination were reported throughout the study. <italic>Conclusion</italic>: When administered to European school-age children, MenACWY-TT has a clinically acceptable safety profile and, when compared with MenC-CRM<sub>197</sub>, the potential to broaden protection against meningococcal disease caused by serogroups A, W-135 and Y while maintaining protection against MenC. This study has been registered at <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link> NCT00674583.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Andrews, N" uniqKey="Andrews N">N Andrews</name></author><author><name sortKey="Borrow, R" uniqKey="Borrow R">R Borrow</name></author><author><name sortKey="Miller, E" uniqKey="Miller E">E Miller</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Antignac, A" uniqKey="Antignac A">A Antignac</name></author><author><name sortKey="Ducos Galand, M" uniqKey="Ducos Galand M">M Ducos-Galand</name></author><author><name sortKey="Guiyoule, A" uniqKey="Guiyoule A">A Guiyoule</name></author><author><name sortKey="Pires, R" uniqKey="Pires R">R Pirès</name></author><author><name sortKey="Alonso, J M" uniqKey="Alonso J">J-M Alonso</name></author><author><name sortKey="Taha, M K" uniqKey="Taha M">M-K 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Konstantopoulos</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Vesikari, T" uniqKey="Vesikari T">T Vesikari</name></author><author><name sortKey="Karvonen, A" uniqKey="Karvonen A">A Karvonen</name></author><author><name sortKey="Bianco, V" uniqKey="Bianco V">V Bianco</name></author><author><name sortKey="Van Der Wielen, M" uniqKey="Van Der Wielen M">M Van der Wielen</name></author><author><name sortKey="Miller, J" uniqKey="Miller J">J Miller</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li><li>États-Unis</li></country><region><li>Berlin</li><li>Pennsylvanie</li><li>Provence-Alpes-Côte d'Azur</li><li>Rhénanie-Palatinat</li><li>Vienne (Autriche)</li><li>Île-de-France</li></region><settlement><li>Berlin</li><li>Clamart</li><li>Mayence</li><li>Nice</li><li>Vienne (Autriche)</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Knuf, Markus" sort="Knuf, Markus" uniqKey="Knuf M" first="Markus" last="Knuf">Markus Knuf</name></noRegion><name sortKey="Fischbach, Thomas" sort="Fischbach, Thomas" uniqKey="Fischbach T" first="Thomas" last="Fischbach">Thomas Fischbach</name><name sortKey="Kieninger Baum, Dorothee" sort="Kieninger Baum, Dorothee" uniqKey="Kieninger Baum D" first="Dorothee" last="Kieninger-Baum">Dorothee Kieninger-Baum</name><name sortKey="Kindler, Klaus" sort="Kindler, Klaus" uniqKey="Kindler K" first="Klaus" last="Kindler">Klaus Kindler</name><name sortKey="Knuf, Markus" sort="Knuf, Markus" uniqKey="Knuf M" first="Markus" last="Knuf">Markus Knuf</name><name sortKey="Pankow Culot, Heidemarie" sort="Pankow Culot, Heidemarie" uniqKey="Pankow Culot H" first="Heidemarie" last="Pankow-Culot">Heidemarie Pankow-Culot</name><name sortKey="Walther, Uta" sort="Walther, Uta" uniqKey="Walther U" first="Uta" last="Walther">Uta Walther</name></country><country name="France"><region name="Île-de-France"><name sortKey="Romain, Olivier" sort="Romain, Olivier" uniqKey="Romain O" first="Olivier" last="Romain">Olivier Romain</name></region><name sortKey="Tran, Phu My" sort="Tran, Phu My" uniqKey="Tran P" first="Phu-My" last="Tran">Phu-My Tran</name></country><country name="Belgique"><region name="Vienne (Autriche)"><name sortKey="Bianco, Veronique" sort="Bianco, Veronique" uniqKey="Bianco V" first="Véronique" last="Bianco">Véronique Bianco</name></region></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Baine, Yaela" sort="Baine, Yaela" uniqKey="Baine Y" first="Yaela" last="Baine">Yaela Baine</name></region><name sortKey="Miller, Jacqueline" sort="Miller, Jacqueline" uniqKey="Miller J" first="Jacqueline" last="Miller">Jacqueline Miller</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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