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 : 000780 ( Main/Exploration ); précédent : 000779; suivant : 000781Extended 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 [France] ; Xavier Duval [France] ; Serge Fitoussi [France] ; Wolfgang Jilg [Allemagne] ; Angkool Kerdpanich [Thaïlande] ; May Montellano [Philippines] ; Tino Schwarz [Allemagne] ; Veerachai Watanveerade [Thaïlande] ; Jürgen Wenzel [Allemagne] ; Gerard Zalcman [France] ; Vinod Bambure [Inde] ; Ping Li [États-Unis] ; Adrian Caplanusi [Belgique] ; Anuradha Madan [États-Unis] ; Paul Gillard [Belgique] ; David Vaughn [États-Unis]Source :
- BMC Infectious Diseases [ 1471-2334 ] ; 2013-09-16.
English descriptors
- 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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Le document en format XML
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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 - 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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><country>Thaïlande</country></affiliation></author><author><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name><affiliation wicri:level="1"><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><country>Philippines</country></affiliation></author><author><name sortKey="Schwarz, Tino" sort="Schwarz, Tino" uniqKey="Schwarz T" first="Tino" last="Schwarz">Tino Schwarz</name><affiliation wicri:level="1"><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><country>Allemagne</country></affiliation></author><author><name sortKey="Watanveerade, Veerachai" sort="Watanveerade, Veerachai" uniqKey="Watanveerade V" first="Veerachai" last="Watanveerade">Veerachai Watanveerade</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-232783" status="INCOMING"> <orgName>Infectious Diseases Unit</orgName> <desc> <address> <addrLine>Department of Pediatrics, 315 Ratchvidhi Rd. 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(GSK Rx India)</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation><country>Inde</country></affiliation></author><author><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name><affiliation wicri:level="1"><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><country>États-Unis</country></affiliation></author><author><name sortKey="Caplanusi, Adrian" sort="Caplanusi, Adrian" uniqKey="Caplanusi A" first="Adrian" last="Caplanusi">Adrian Caplanusi</name><affiliation wicri:level="1"><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><country>Belgique</country></affiliation></author><author><name sortKey="Madan, Anuradha" sort="Madan, Anuradha" uniqKey="Madan A" first="Anuradha" last="Madan">Anuradha Madan</name><affiliation wicri:level="1"><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><country>États-Unis</country></affiliation></author><author><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul Gillard</name><affiliation wicri:level="1"><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><country>Belgique</country></affiliation></author><author><name sortKey="Vaughn, David" sort="Vaughn, David" uniqKey="Vaughn D" first="David" last="Vaughn">David Vaughn</name><affiliation wicri:level="1"><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><country>États-Unis</country></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><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li><li>Inde</li><li>Philippines</li><li>Thaïlande</li><li>États-Unis</li></country></list><tree><country name="France"><noRegion><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name></noRegion><name sortKey="Duval, Xavier" sort="Duval, Xavier" uniqKey="Duval X" first="Xavier" last="Duval">Xavier Duval</name><name sortKey="Fitoussi, Serge" sort="Fitoussi, Serge" uniqKey="Fitoussi S" first="Serge" last="Fitoussi">Serge Fitoussi</name><name sortKey="Zalcman, Gerard" sort="Zalcman, Gerard" uniqKey="Zalcman G" first="Gerard" last="Zalcman">Gerard Zalcman</name></country><country name="Allemagne"><noRegion><name sortKey="Jilg, Wolfgang" sort="Jilg, Wolfgang" uniqKey="Jilg W" first="Wolfgang" last="Jilg">Wolfgang Jilg</name></noRegion><name sortKey="Schwarz, Tino" sort="Schwarz, Tino" uniqKey="Schwarz T" first="Tino" last="Schwarz">Tino Schwarz</name><name sortKey="Wenzel, Jurgen" sort="Wenzel, Jurgen" uniqKey="Wenzel J" first="Jürgen" last="Wenzel">Jürgen Wenzel</name></country><country name="Thaïlande"><noRegion><name sortKey="Kerdpanich, Angkool" sort="Kerdpanich, Angkool" uniqKey="Kerdpanich A" first="Angkool" last="Kerdpanich">Angkool Kerdpanich</name></noRegion><name sortKey="Watanveerade, Veerachai" sort="Watanveerade, Veerachai" uniqKey="Watanveerade V" first="Veerachai" last="Watanveerade">Veerachai Watanveerade</name></country><country name="Philippines"><noRegion><name sortKey="Montellano, May" sort="Montellano, May" uniqKey="Montellano M" first="May" last="Montellano">May Montellano</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Bambure, Vinod" sort="Bambure, Vinod" uniqKey="Bambure V" first="Vinod" last="Bambure">Vinod Bambure</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Li, Ping" sort="Li, Ping" uniqKey="Li P" first="Ping" last="Li">Ping Li</name></noRegion><name sortKey="Madan, Anuradha" sort="Madan, Anuradha" uniqKey="Madan A" first="Anuradha" last="Madan">Anuradha Madan</name><name sortKey="Vaughn, David" sort="Vaughn, David" uniqKey="Vaughn D" first="David" last="Vaughn">David Vaughn</name></country><country name="Belgique"><noRegion><name sortKey="Caplanusi, Adrian" sort="Caplanusi, Adrian" uniqKey="Caplanusi A" first="Adrian" last="Caplanusi">Adrian Caplanusi</name></noRegion><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul Gillard</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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