Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.
Identifieur interne : 000098 ( Hal/Corpus ); précédent : 000097; suivant : 000099Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.
Auteurs : Odile Launay ; Xavier Duval ; Serge Fitoussi ; Wolfgang Jilg ; Angkool Kerdpanich ; May Montellano ; Tino Schwarz ; Veerachai Watanveerade ; Jürgen Wenzel ; Gerard Zalcman ; Vinod Bambure ; Ping Li ; Adrian Caplanusi ; Anuradha Madan ; Paul Gillard ; David VaughnSource :
- BMC Infectious Diseases [ 1471-2334 ] ; 2013-09-16.
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- mix :
Abstract
BACKGROUND: Pandemicinfluenza vaccinemanufacturing capacity and distribution agility is enhanced through the availabilityof equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines' A/California/7/2009(H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan). METHODS: In two studies,334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 mug haemagglutinin antigen (HA) adjuvanted with AS03Aadministered21 days apart, and 209 children 3-9 years of age received 1reduced dose of D-Panor Q-Pan (0.9 mug HA) or Q-Pan (1.9 mug HA) with AS03B. Haemagglutination inhibition (HI)titres were assessed before and 21 days post-vaccination. HI persistence was assessed after 12 months in adults and 6 months in children. RESULTS: Pre-defined criteria for immunological equivalence of Q-Pan versus D-Pan were achieved in both populations. After one vaccine dose, >=97.6% of adults and children had HI titres >=1:40, with increases in titre>=25.7-fold. CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21. In adults,the percentage with HI titres >=1:40 at Month 12 was 82.9% (Q-Pan) and 84.0% (D-Pan). In children, the percentages at Month 6 were 75.3.3% (Q-Pan0.9), 85.1% (D-Pan0.9) and 79.3% (Q-Pan1.9). Safety profile of the study vaccines was consistent with previously published data. CONCLUSION: Two studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sitesand combined with AS03 are equivalent in terms of immunogenicity in adults and children and highly immunogenic. Different HA doses elicited an adequate immune response through 180 days post-vaccination in children 3-9 years of age.Trial registrationClinicalTrials.gov: NCT00979407 and NCT01161160.
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DOI: 10.1186/1471-2334-13-435
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Hal:inserm-00868824Le document en format XML
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Wavre</addrLine> <country key="BE"></country> </address> </desc> <listRelation> <relation active="#struct-356463" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356463" type="direct"><org type="institution" xml:id="struct-356463" status="INCOMING"> <orgName>GlaxoSmithKline - Site de Wavre-Nord</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Madan, Anuradha" sort="Madan, Anuradha" uniqKey="Madan A" first="Anuradha" last="Madan">Anuradha Madan</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232789" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [King of Prussia]</orgName> <desc> <address> <addrLine>North America (NA) Head, Regulatory Affairs - Vaccines - King of Prussia, PA</addrLine> <country key="US"></country> </address> </desc> <listRelation> <relation active="#struct-356462" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356462" type="direct"><org type="institution" xml:id="struct-356462" status="VALID"> <orgName>GlaxoSmithKline [King of Prussia]</orgName> <orgName type="acronym">GSK</orgName> <desc> <address> <addrLine>King of Prussia, PA,</addrLine> <country key="US"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul Gillard</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232790" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [Wavre]</orgName> <desc> <address> <addrLine>Parc de la Noire Epine Rue Fleming, 20 1300 - Wavre</addrLine> <country key="BE"></country> </address> </desc> <listRelation> <relation active="#struct-356463" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356463" type="direct"><org type="institution" xml:id="struct-356463" status="INCOMING"> <orgName>GlaxoSmithKline - Site de Wavre-Nord</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Vaughn, David" sort="Vaughn, David" uniqKey="Vaughn D" first="David" last="Vaughn">David Vaughn</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232789" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [King of Prussia]</orgName> <desc> <address> <addrLine>North America (NA) Head, Regulatory Affairs - Vaccines - King of Prussia, PA</addrLine> <country key="US"></country> </address> </desc> <listRelation> <relation active="#struct-356462" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356462" type="direct"><org type="institution" xml:id="struct-356462" status="VALID"> <orgName>GlaxoSmithKline [King of Prussia]</orgName> <orgName type="acronym">GSK</orgName> <desc> <address> <addrLine>King of Prussia, PA,</addrLine> <country key="US"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">HAL</idno><idno type="RBID">Hal:inserm-00868824</idno><idno type="halId">inserm-00868824</idno><idno type="halUri">https://www.hal.inserm.fr/inserm-00868824</idno><idno type="url">https://www.hal.inserm.fr/inserm-00868824</idno><idno type="doi">10.1186/1471-2334-13-435</idno><date when="2013-09-16">2013-09-16</date><idno type="wicri:Area/Hal/Corpus">000098</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.</title><author><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232778" status="INCOMING"> <orgName>REseau national d'Investigation clinique en VACcinologie</orgName> <orgName type="acronym">REIVAC</orgName> <desc> <address> <addrLine>Bâtiment Lavoisier - 27, rue du Faubourg Saint Jacques - 75014 PARIS</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-356457" type="direct"></relation> <relation active="#struct-303623" type="direct"></relation> <relation active="#struct-302361" type="direct"></relation> <relation active="#struct-300142" type="direct"></relation> <relation active="#struct-300123" type="direct"></relation> <relation active="#struct-300068" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356457" type="direct"><org type="institution" xml:id="struct-356457" status="INCOMING"> <orgName>Centre National de Gestion des Essais de Produits de Santé (CeNGEPS)</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle><tutelle active="#struct-302361" type="direct"><org type="institution" xml:id="struct-302361" status="VALID"> <orgName>Groupe hospitalier Broca</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-300142" type="direct"><org type="institution" xml:id="struct-300142" status="VALID"> <orgName>Hôtel-Dieu</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-300123" type="direct"><org type="institution" xml:id="struct-300123" status="VALID"> <orgName>CHU Cochin [AP-HP]</orgName> <desc> <address> <addrLine>27 Rue du Faubourg Saint-Jacques 75014 Paris</addrLine> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-300068" type="direct"><org type="regroupinstitution" xml:id="struct-300068" status="VALID"> <orgName>Assistance publique - Hôpitaux de Paris (AP-HP)</orgName> <orgName type="acronym">APHP</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Duval, Xavier" sort="Duval, Xavier" uniqKey="Duval X" first="Xavier" last="Duval">Xavier Duval</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-2607" status="VALID"> <orgName>CIC - CHU Bichat</orgName> <desc> <address> <addrLine>Gh Xavier Bichat - Claude Bernard PARIS VII 46, Rue Henri Huchard 75018 PARIS</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CIC7" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CIC7" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Fitoussi, Serge" sort="Fitoussi, Serge" uniqKey="Fitoussi S" first="Serge" last="Fitoussi">Serge Fitoussi</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232781" status="INCOMING"> <orgName>Essais Cliniques de Phase 1 à 2A</orgName> <desc> <address> <addrLine>6 avenue Mozart 86000 Poitiers</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-356458" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356458" type="direct"><org type="institution" xml:id="struct-356458" status="INCOMING"> <orgName>Mediscis : Medical Science Services</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Jilg, Wolfgang" sort="Jilg, Wolfgang" uniqKey="Jilg W" first="Wolfgang" last="Jilg">Wolfgang Jilg</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232782" status="VALID"> <orgName>Institute of Medical Microbiology and Hygiene</orgName> <orgName type="acronym">IMHR</orgName> <desc> <address> <addrLine>Universitätsstraße 31, 93053 Regensburg</addrLine> <country key="DE"></country> </address> <ref type="url">https://www.imhr.de/en/</ref> </desc> <listRelation> <relation active="#struct-303027" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-303027" type="direct"><org type="institution" xml:id="struct-303027" status="VALID"> <orgName>Universität Regensburg</orgName> <orgName type="acronym">UR</orgName> <date type="start">2016-10-17</date> <desc> <address> <addrLine>Universitätsstraße 31, 93053 Regensburg</addrLine> <country key="DE"></country> </address> <ref type="url">http://www.uni-regensburg.de</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Kerdpanich, Angkool" sort="Kerdpanich, Angkool" uniqKey="Kerdpanich A" first="Angkool" last="Kerdpanich">Angkool Kerdpanich</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232783" status="INCOMING"> <orgName>Infectious Diseases Unit</orgName> <desc> <address> <addrLine>Department of Pediatrics, 315 Ratchvidhi Rd. Thung Phyathai, Ratchthewi Bangkok 10400</addrLine> <country key="TH"></country> </address> </desc> <listRelation> <relation active="#struct-356459" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356459" type="direct"><org type="institution" xml:id="struct-356459" status="INCOMING"> <orgName>Phramongkutklao Hospital, Bangkok</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232784" status="INCOMING"> <orgName>Department of Pediatrics</orgName> <desc> <address> <addrLine>667 Gastambide St.,Sampaloc, Manila</addrLine> <country key="PH"></country> </address> </desc> <listRelation> <relation active="#struct-356261" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356261" type="direct"><org type="institution" xml:id="struct-356261" status="INCOMING"> <orgName>Mary Chiles General Hospital</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Schwarz, Tino" sort="Schwarz, Tino" uniqKey="Schwarz T" first="Tino" last="Schwarz">Tino Schwarz</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232785" status="INCOMING"> <orgName>Central Laboratory and Vaccination Centre</orgName> <desc> <address> <addrLine>Klinikstrasse 1 - D 97070 Würzburg</addrLine> <country key="DE"></country> </address> </desc> <listRelation> <relation active="#struct-356262" type="direct"></relation> <relation active="#struct-356460" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356262" type="direct"><org type="institution" xml:id="struct-356262" status="INCOMING"> <orgName>StiftungJuliusspital</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-356460" type="direct"><org type="institution" xml:id="struct-356460" status="INCOMING"> <orgName>StiftungJuliusspital Würzburg</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Watanveerade, Veerachai" sort="Watanveerade, Veerachai" uniqKey="Watanveerade V" first="Veerachai" last="Watanveerade">Veerachai Watanveerade</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232783" status="INCOMING"> <orgName>Infectious Diseases Unit</orgName> <desc> <address> <addrLine>Department of Pediatrics, 315 Ratchvidhi Rd. Thung Phyathai, Ratchthewi Bangkok 10400</addrLine> <country key="TH"></country> </address> </desc> <listRelation> <relation active="#struct-356459" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356459" type="direct"><org type="institution" xml:id="struct-356459" status="INCOMING"> <orgName>Phramongkutklao Hospital, Bangkok</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Wenzel, Jurgen" sort="Wenzel, Jurgen" uniqKey="Wenzel J" first="Jürgen" last="Wenzel">Jürgen Wenzel</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232782" status="VALID"> <orgName>Institute of Medical Microbiology and Hygiene</orgName> <orgName type="acronym">IMHR</orgName> <desc> <address> <addrLine>Universitätsstraße 31, 93053 Regensburg</addrLine> <country key="DE"></country> </address> <ref type="url">https://www.imhr.de/en/</ref> </desc> <listRelation> <relation active="#struct-303027" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-303027" type="direct"><org type="institution" xml:id="struct-303027" status="VALID"> <orgName>Universität Regensburg</orgName> <orgName type="acronym">UR</orgName> <date type="start">2016-10-17</date> <desc> <address> <addrLine>Universitätsstraße 31, 93053 Regensburg</addrLine> <country key="DE"></country> </address> <ref type="url">http://www.uni-regensburg.de</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Zalcman, Gerard" sort="Zalcman, Gerard" uniqKey="Zalcman G" first="Gerard" last="Zalcman">Gerard Zalcman</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-149166" status="VALID"> <orgName>Centre de recherche clinique [CHU Caen]</orgName> <orgName type="acronym">CRC</orgName> <desc> <address> <addrLine>Centre Hospitalier UniversitaireAvenue de la Côte de NacreCS 3000114033 CAEN cedex 9</addrLine> <country key="FR"></country> </address> <ref type="url">https://www.chu-caen.fr/crcbn.html</ref> </desc> <listRelation> <relation active="#struct-7127" type="direct"></relation> <relation active="#struct-455934" type="indirect"></relation> <relation active="#struct-300185" type="direct"></relation> <relation active="#struct-575575" type="indirect"></relation> <relation active="#struct-301261" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-7127" type="direct"><org type="institution" xml:id="struct-7127" status="VALID"> <idno type="IdRef">026403064</idno> <idno type="ISNI">0000000121864076</idno> <orgName>Université de Caen Normandie</orgName> <orgName type="acronym">UNICAEN</orgName> <date type="start">1432-01-01</date> <desc> <address> <addrLine>Esplanade de la Paix - CS 14032 - 14032 CAEN Cedex 5</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.unicaen.fr/</ref> </desc> <listRelation> <relation active="#struct-455934" type="direct"></relation> </listRelation> </org></tutelle><tutelle active="#struct-455934" type="indirect"><org type="regroupinstitution" xml:id="struct-455934" status="VALID"> <idno type="IdRef">190906332</idno> <idno type="ISNI">0000000417859671 </idno> <orgName>Normandie Université</orgName> <orgName type="acronym">NU</orgName> <date type="start">2015-01-01</date> <desc> <address> <addrLine>Esplanade de la Paix - CS 14032 - 14032 Caen Cedex 5</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.normandie-univ.fr/</ref> </desc> </org></tutelle><tutelle active="#struct-300185" type="direct"><org type="institution" xml:id="struct-300185" status="VALID"> <idno type="IdRef">031245382</idno> <orgName>CHU Caen</orgName> <desc> <address> <addrLine>Avenue de la Côte de Nacre 14000 Caen</addrLine> <country key="FR"></country> </address> <ref type="url">https://www.chu-caen.fr/</ref> </desc> <listRelation> <relation active="#struct-455934" type="direct"></relation> <relation active="#struct-575575" type="direct"></relation> </listRelation> </org></tutelle><tutelle active="#struct-575575" type="indirect"><org type="regroupinstitution" xml:id="struct-575575" status="VALID"> <orgName>Tumorothèque de Caen Basse-Normandie</orgName> <orgName type="acronym">TCBN</orgName> <desc> <address> <addrLine>3 avenue du Général Harris14076 Caen cedex 5</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.tumorotheque-caen-basse-normandie.org/</ref> </desc> </org></tutelle><tutelle active="#struct-301261" type="direct"><org type="institution" xml:id="struct-301261" status="VALID"> <idno type="ISNI">0000 0001 2106 7843 </idno> <idno type="IdRef">031239218</idno> <orgName>Centre Régional de Lutte contre le Cancer François Baclesse </orgName> <orgName type="acronym">CRLC François Baclesse </orgName> <desc> <address> <addrLine>3 avenue général Harris14000 Caen</addrLine> <country key="FR"></country> </address> <ref type="url">https://www.baclesse.fr/</ref> </desc> <listRelation> <relation active="#struct-455934" type="direct"></relation> <relation active="#struct-575575" type="direct"></relation> </listRelation> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Bambure, Vinod" sort="Bambure, Vinod" uniqKey="Bambure V" first="Vinod" last="Bambure">Vinod Bambure</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232788" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [Bangalore]</orgName> <desc> <address> <addrLine>Bangalore</addrLine> <country key="IN"></country> </address> </desc> <listRelation> <relation active="#struct-356461" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356461" type="direct"><org type="institution" xml:id="struct-356461" status="INCOMING"> <orgName>India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India)</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232789" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [King of Prussia]</orgName> <desc> <address> <addrLine>North America (NA) Head, Regulatory Affairs - Vaccines - King of Prussia, PA</addrLine> <country key="US"></country> </address> </desc> <listRelation> <relation active="#struct-356462" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356462" type="direct"><org type="institution" xml:id="struct-356462" status="VALID"> <orgName>GlaxoSmithKline [King of Prussia]</orgName> <orgName type="acronym">GSK</orgName> <desc> <address> <addrLine>King of Prussia, PA,</addrLine> <country key="US"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Caplanusi, Adrian" sort="Caplanusi, Adrian" uniqKey="Caplanusi A" first="Adrian" last="Caplanusi">Adrian Caplanusi</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232790" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [Wavre]</orgName> <desc> <address> <addrLine>Parc de la Noire Epine Rue Fleming, 20 1300 - Wavre</addrLine> <country key="BE"></country> </address> </desc> <listRelation> <relation active="#struct-356463" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356463" type="direct"><org type="institution" xml:id="struct-356463" status="INCOMING"> <orgName>GlaxoSmithKline - Site de Wavre-Nord</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Madan, Anuradha" sort="Madan, Anuradha" uniqKey="Madan A" first="Anuradha" last="Madan">Anuradha Madan</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232789" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [King of Prussia]</orgName> <desc> <address> <addrLine>North America (NA) Head, Regulatory Affairs - Vaccines - King of Prussia, PA</addrLine> <country key="US"></country> </address> </desc> <listRelation> <relation active="#struct-356462" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356462" type="direct"><org type="institution" xml:id="struct-356462" status="VALID"> <orgName>GlaxoSmithKline [King of Prussia]</orgName> <orgName type="acronym">GSK</orgName> <desc> <address> <addrLine>King of Prussia, PA,</addrLine> <country key="US"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul Gillard</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232790" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [Wavre]</orgName> <desc> <address> <addrLine>Parc de la Noire Epine Rue Fleming, 20 1300 - Wavre</addrLine> <country key="BE"></country> </address> </desc> <listRelation> <relation active="#struct-356463" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356463" type="direct"><org type="institution" xml:id="struct-356463" status="INCOMING"> <orgName>GlaxoSmithKline - Site de Wavre-Nord</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Vaughn, David" sort="Vaughn, David" uniqKey="Vaughn D" first="David" last="Vaughn">David Vaughn</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-232789" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [King of Prussia]</orgName> <desc> <address> <addrLine>North America (NA) Head, Regulatory Affairs - Vaccines - King of Prussia, PA</addrLine> <country key="US"></country> </address> </desc> <listRelation> <relation active="#struct-356462" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-356462" type="direct"><org type="institution" xml:id="struct-356462" status="VALID"> <orgName>GlaxoSmithKline [King of Prussia]</orgName> <orgName type="acronym">GSK</orgName> <desc> <address> <addrLine>King of Prussia, PA,</addrLine> <country key="US"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author></analytic><idno type="DOI">10.1186/1471-2334-13-435</idno><series><title level="j">BMC Infectious Diseases</title><idno type="ISSN">1471-2334</idno><imprint><date type="datePub">2013-09-16</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="mix" xml:lang="en"><term>Adults</term><term>Antigen dose reduction</term><term>Children</term><term>H1N1</term><term>Immunogenicity</term><term>Influenza virus</term><term>Manufacturing capacity</term><term>Pandemic influenza vaccine</term><term>Persistence</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"> <p>BACKGROUND: Pandemicinfluenza vaccinemanufacturing capacity and distribution agility is enhanced through the availabilityof equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines' A/California/7/2009(H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan). METHODS: In two studies,334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 mug haemagglutinin antigen (HA) adjuvanted with AS03Aadministered21 days apart, and 209 children 3-9 years of age received 1reduced dose of D-Panor Q-Pan (0.9 mug HA) or Q-Pan (1.9 mug HA) with AS03B. Haemagglutination inhibition (HI)titres were assessed before and 21 days post-vaccination. HI persistence was assessed after 12 months in adults and 6 months in children. RESULTS: Pre-defined criteria for immunological equivalence of Q-Pan versus D-Pan were achieved in both populations. After one vaccine dose, >=97.6% of adults and children had HI titres >=1:40, with increases in titre>=25.7-fold. CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21. In adults,the percentage with HI titres >=1:40 at Month 12 was 82.9% (Q-Pan) and 84.0% (D-Pan). In children, the percentages at Month 6 were 75.3.3% (Q-Pan0.9), 85.1% (D-Pan0.9) and 79.3% (Q-Pan1.9). Safety profile of the study vaccines was consistent with previously published data. CONCLUSION: Two studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sitesand combined with AS03 are equivalent in terms of immunogenicity in adults and children and highly immunogenic. Different HA doses elicited an adequate immune response through 180 days post-vaccination in children 3-9 years of age.Trial registrationClinicalTrials.gov: NCT00979407 and NCT01161160.</p> </div></front></TEI><hal api="V3"> <titleStmt> <title xml:lang="en">Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.</title> <author role="crp"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-232778"></affiliation> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <email type="md5">9b28f7a5ea1b2abe59e3e0af156b5172</email> <email type="domain">bch.aphp.fr</email> <idno type="halauthorid">381331</idno> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Serge</forename> <surname>Fitoussi</surname> </persName> <email type="md5">76279f3549a6ab1ada9efdb14f2d7b83</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895146</idno> <affiliation ref="#struct-232781"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Wolfgang</forename> <surname>Jilg</surname> </persName> <email type="md5">db8d920ef75422e53b71c711ab84fcb2</email> <email type="domain">klinik.uni-regensburg.de</email> <idno type="halauthorid">895147</idno> <affiliation ref="#struct-232782"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Angkool</forename> <surname>Kerdpanich</surname> </persName> <email type="md5">d4c4b37c6002a0c9b923c2f2cb845e47</email> <email type="domain">yahoo.com</email> <idno type="halauthorid">895148</idno> <affiliation ref="#struct-232783"></affiliation> </author> <author role="aut"> <persName> <forename type="first">May</forename> <surname>Montellano</surname> </persName> <email type="md5">ae531376d5a41cb696df8262424c8899</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895149</idno> <affiliation ref="#struct-232784"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Tino</forename> <surname>Schwarz</surname> </persName> <email type="md5">c4fab12b27d679ef541c1a645b0f6868</email> <email type="domain">juliusspital.de</email> <idno type="halauthorid">895150</idno> <affiliation ref="#struct-232785"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Veerachai</forename> <surname>Watanveerade</surname> </persName> <email type="md5">2d7e1284a06ca1446f9de79a125c0c4d</email> <email type="domain">yahoo.com</email> <idno type="halauthorid">895151</idno> <affiliation ref="#struct-232783"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jürgen</forename> <surname>Wenzel</surname> </persName> <email type="md5">b3fe73381ccddcbae7633974734bca2c</email> <email type="domain">klinik.uni-regensburg.de</email> <idno type="halauthorid">895152</idno> <affiliation ref="#struct-232782"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Gerard</forename> <surname>Zalcman</surname> </persName> <email type="md5">1cf190d23dd73a5ec10701ac650caf83</email> <email type="domain">yahoo.fr</email> <idno type="halauthorid">895153</idno> <affiliation ref="#struct-149166"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Vinod</forename> <surname>Bambure</surname> </persName> <email type="md5">8bf9082c569049818889a067de84c79f</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895154</idno> <affiliation ref="#struct-232788"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Ping</forename> <surname>Li</surname> </persName> <email type="md5">9c6aa6b1f238756d38f31f572e83aab6</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895155</idno> <affiliation ref="#struct-232789"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Adrian</forename> <surname>Caplanusi</surname> </persName> <email type="md5">dc2244dd16713ab655f75d449941c649</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895156</idno> <affiliation ref="#struct-232790"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Anuradha</forename> <surname>Madan</surname> </persName> <email type="md5">5b7812767075aea6fa2ca8f789b64484</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895157</idno> <affiliation ref="#struct-232789"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Paul</forename> <surname>Gillard</surname> </persName> <email type="md5">7651fb04444db20e1380c2e39217b382</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895158</idno> <affiliation ref="#struct-232790"></affiliation> </author> <author role="aut"> <persName> <forename type="first">David</forename> <surname>Vaughn</surname> </persName> <email type="md5">d33a7676b8dd5ad875a17830e103cdee</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895159</idno> <affiliation ref="#struct-232789"></affiliation> </author> <editor role="depositor"> <persName> <forename>Ed.</forename> <surname>BMC</surname> </persName> <email type="md5">440c6e58a5bd861e373d54bc5e68a1a4</email> <email type="domain">biomedcentral.com</email> </editor> <funder>GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present manuscript.</funder> </titleStmt> <editionStmt> <edition n="v1" type="current"> <date type="whenSubmitted">2013-10-02 06:20:18</date> <date type="whenModified">2020-02-14 14:22:11</date> <date type="whenReleased">2013-10-16 11:55:29</date> <date type="whenProduced">2013-09-16</date> <date type="whenEndEmbargoed">2013-10-02</date> <ref type="file" target="https://www.hal.inserm.fr/inserm-00868824/document"> <date notBefore="2013-10-02"></date> </ref> <ref type="file" subtype="greenPublisher" n="1" target="https://www.hal.inserm.fr/inserm-00868824/file/1471-2334-13-435.pdf"> <date notBefore="2013-10-02"></date> </ref> <ref type="annex" subtype="other" n="0" target="https://www.hal.inserm.fr/inserm-00868824/file/1471-2334-13-435.xml"> <date notBefore="2013-10-02"></date> </ref> <ref type="externalLink" target="https://bmcinfectdis.biomedcentral.com/track/pdf/10.1186/1471-2334-13-435"></ref> </edition> <respStmt> <resp>contributor</resp> <name key="151596"> <persName> <forename>Ed.</forename> <surname>BMC</surname> </persName> <email type="md5">440c6e58a5bd861e373d54bc5e68a1a4</email> <email type="domain">biomedcentral.com</email> </name> </respStmt> </editionStmt> <publicationStmt> <distributor>CCSD</distributor> <idno type="halId">inserm-00868824</idno> <idno type="halUri">https://www.hal.inserm.fr/inserm-00868824</idno> <idno type="halBibtex">launay:inserm-00868824</idno> <idno type="halRefHtml">BMC Infectious Diseases, BioMed Central, 2013, 13 (1), pp.435. ⟨10.1186/1471-2334-13-435⟩</idno> <idno type="halRef">BMC Infectious Diseases, BioMed Central, 2013, 13 (1), pp.435. ⟨10.1186/1471-2334-13-435⟩</idno> </publicationStmt> <seriesStmt> <idno type="stamp" n="INSERM">INSERM - Institut national de la santé et de la recherche médicale</idno> <idno type="stamp" n="PASTEUR">Institut Pasteur</idno> <idno type="stamp" n="RIIP_PARIS">Institut Pasteur de Paris</idno> <idno type="stamp" n="APHP" corresp="INSERM">AP-HP</idno> <idno type="stamp" n="LORIA2">Publications du LORIA</idno> <idno type="stamp" n="COMUE-NORMANDIE">Normandie Université</idno> <idno type="stamp" n="UNICAEN" corresp="COMUE-NORMANDIE">Université de Caen Normandie</idno> </seriesStmt> <notesStmt> <note type="audience" n="2">International</note> <note type="popular" n="0">No</note> <note type="peer" n="1">Yes</note> </notesStmt> <sourceDesc> <biblStruct> <analytic> <title xml:lang="en">Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.</title> <author role="crp"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-232778"></affiliation> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <email type="md5">9b28f7a5ea1b2abe59e3e0af156b5172</email> <email type="domain">bch.aphp.fr</email> <idno type="halauthorid">381331</idno> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Serge</forename> <surname>Fitoussi</surname> </persName> <email type="md5">76279f3549a6ab1ada9efdb14f2d7b83</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895146</idno> <affiliation ref="#struct-232781"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Wolfgang</forename> <surname>Jilg</surname> </persName> <email type="md5">db8d920ef75422e53b71c711ab84fcb2</email> <email type="domain">klinik.uni-regensburg.de</email> <idno type="halauthorid">895147</idno> <affiliation ref="#struct-232782"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Angkool</forename> <surname>Kerdpanich</surname> </persName> <email type="md5">d4c4b37c6002a0c9b923c2f2cb845e47</email> <email type="domain">yahoo.com</email> <idno type="halauthorid">895148</idno> <affiliation ref="#struct-232783"></affiliation> </author> <author role="aut"> <persName> <forename type="first">May</forename> <surname>Montellano</surname> </persName> <email type="md5">ae531376d5a41cb696df8262424c8899</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895149</idno> <affiliation ref="#struct-232784"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Tino</forename> <surname>Schwarz</surname> </persName> <email type="md5">c4fab12b27d679ef541c1a645b0f6868</email> <email type="domain">juliusspital.de</email> <idno type="halauthorid">895150</idno> <affiliation ref="#struct-232785"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Veerachai</forename> <surname>Watanveerade</surname> </persName> <email type="md5">2d7e1284a06ca1446f9de79a125c0c4d</email> <email type="domain">yahoo.com</email> <idno type="halauthorid">895151</idno> <affiliation ref="#struct-232783"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jürgen</forename> <surname>Wenzel</surname> </persName> <email type="md5">b3fe73381ccddcbae7633974734bca2c</email> <email type="domain">klinik.uni-regensburg.de</email> <idno type="halauthorid">895152</idno> <affiliation ref="#struct-232782"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Gerard</forename> <surname>Zalcman</surname> </persName> <email type="md5">1cf190d23dd73a5ec10701ac650caf83</email> <email type="domain">yahoo.fr</email> <idno type="halauthorid">895153</idno> <affiliation ref="#struct-149166"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Vinod</forename> <surname>Bambure</surname> </persName> <email type="md5">8bf9082c569049818889a067de84c79f</email> <email type="domain">gmail.com</email> <idno type="halauthorid">895154</idno> <affiliation ref="#struct-232788"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Ping</forename> <surname>Li</surname> </persName> <email type="md5">9c6aa6b1f238756d38f31f572e83aab6</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895155</idno> <affiliation ref="#struct-232789"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Adrian</forename> <surname>Caplanusi</surname> </persName> <email type="md5">dc2244dd16713ab655f75d449941c649</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895156</idno> <affiliation ref="#struct-232790"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Anuradha</forename> <surname>Madan</surname> </persName> <email type="md5">5b7812767075aea6fa2ca8f789b64484</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895157</idno> <affiliation ref="#struct-232789"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Paul</forename> <surname>Gillard</surname> </persName> <email type="md5">7651fb04444db20e1380c2e39217b382</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895158</idno> <affiliation ref="#struct-232790"></affiliation> </author> <author role="aut"> <persName> <forename type="first">David</forename> <surname>Vaughn</surname> </persName> <email type="md5">d33a7676b8dd5ad875a17830e103cdee</email> <email type="domain">gsk.com</email> <idno type="halauthorid">895159</idno> <affiliation ref="#struct-232789"></affiliation> </author> </analytic> <monogr> <idno type="halJournalId" status="VALID">337</idno> <idno type="issn">1471-2334</idno> <idno type="eissn">1471-2334</idno> <title level="j">BMC Infectious Diseases</title> <imprint> <publisher>BioMed Central</publisher> <biblScope unit="volume">13</biblScope> <biblScope unit="issue">1</biblScope> <biblScope unit="pp">435</biblScope> <date type="datePub">2013-09-16</date> <date type="dateEpub">2013-09-16</date> </imprint> </monogr> <idno type="doi">10.1186/1471-2334-13-435</idno> <idno type="pubmed">24041010</idno> </biblStruct> </sourceDesc> <profileDesc> <langUsage> <language ident="en">English</language> </langUsage> <textClass> <keywords scheme="author"> <term xml:lang="en">H1N1</term> <term xml:lang="en">Pandemic influenza vaccine</term> <term xml:lang="en">Influenza virus</term> <term xml:lang="en">Children</term> <term xml:lang="en">Adults</term> <term xml:lang="en">Persistence</term> <term xml:lang="en">Immunogenicity</term> <term xml:lang="en">Manufacturing capacity</term> <term xml:lang="en">Antigen dose reduction</term> </keywords> <classCode scheme="halDomain" n="sdv.mhep.mi">Life Sciences [q-bio]/Human health and pathology/Infectious diseases</classCode> <classCode scheme="halTypology" n="ART">Journal articles</classCode> </textClass> <abstract xml:lang="en"> <p>BACKGROUND: Pandemicinfluenza vaccinemanufacturing capacity and distribution agility is enhanced through the availabilityof equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines' A/California/7/2009(H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan). METHODS: In two studies,334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 mug haemagglutinin antigen (HA) adjuvanted with AS03Aadministered21 days apart, and 209 children 3-9 years of age received 1reduced dose of D-Panor Q-Pan (0.9 mug HA) or Q-Pan (1.9 mug HA) with AS03B. Haemagglutination inhibition (HI)titres were assessed before and 21 days post-vaccination. HI persistence was assessed after 12 months in adults and 6 months in children. RESULTS: Pre-defined criteria for immunological equivalence of Q-Pan versus D-Pan were achieved in both populations. After one vaccine dose, >=97.6% of adults and children had HI titres >=1:40, with increases in titre>=25.7-fold. CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21. In adults,the percentage with HI titres >=1:40 at Month 12 was 82.9% (Q-Pan) and 84.0% (D-Pan). In children, the percentages at Month 6 were 75.3.3% (Q-Pan0.9), 85.1% (D-Pan0.9) and 79.3% (Q-Pan1.9). Safety profile of the study vaccines was consistent with previously published data. CONCLUSION: Two studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sitesand combined with AS03 are equivalent in terms of immunogenicity in adults and children and highly immunogenic. Different HA doses elicited an adequate immune response through 180 days post-vaccination in children 3-9 years of age.Trial registrationClinicalTrials.gov: NCT00979407 and NCT01161160.</p> </abstract> </profileDesc> </hal></record>Pour manipuler ce document sous Unix (Dilib)
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