PandemieGrippaleV1, PascalFrancis, Corpus, bibRecord, 000525

Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons

Identifieur interne : 000525 ( PascalFrancis/Corpus ); précédent : 000524; suivant : 000526

Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons

Auteurs : Lisa A. Jackson ; Wilbur H. Chen ; Jack T. Stapleton ; Cornelia L. Dekker ; Anna Wald ; Rebecca C. Brady ; Srilatha Edupuganti ; Patricia Winokur ; Mark J. Mulligan ; Harry L. Keyserling ; Karen L. Kotloff ; Nadine Rouphael ; Diana L. Noah ; Heather Hill ; Mark C. Wolff

Source :

The Journal of infectious diseases [ 0022-1899 ] ; 2012.

RBID : Pascal:12-0371820

Descripteurs français

Pascal (Inist)
- Virus grippal A, Homme, Immunogénicité, Vaccin, Adjuvant immunologique, Personne âgée, Infection, Grippe A.

English descriptors

KwdEn :
- Elderly, Human, Immunogenicity, Immunological adjuvant, Infection, Influenza A, Influenza A virus, Vaccine.

Abstract

Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A02	`01`			`@0 JIDIAQ`
A03		`1`		`@0 J. infect. dis.`
A05				`@2 206`
A06				`@2 6`
A08	`01`	`1`	`ENG`	`@1 Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons`
A11	`01`	`1`		`@1 JACKSON (Lisa A.)`
A11	`02`	`1`		`@1 CHEN (Wilbur H.)`
A11	`03`	`1`		`@1 STAPLETON (Jack T.)`
A11	`04`	`1`		`@1 DEKKER (Cornelia L.)`
A11	`05`	`1`		`@1 WALD (Anna)`
A11	`06`	`1`		`@1 BRADY (Rebecca C.)`
A11	`07`	`1`		`@1 EDUPUGANTI (Srilatha)`
A11	`08`	`1`		`@1 WINOKUR (Patricia)`
A11	`09`	`1`		`@1 MULLIGAN (Mark J.)`
A11	`10`	`1`		`@1 KEYSERLING (Harry L.)`
A11	`11`	`1`		`@1 KOTLOFF (Karen L.)`
A11	`12`	`1`		`@1 ROUPHAEL (Nadine)`
A11	`13`	`1`		`@1 NOAH (Diana L.)`
A11	`14`	`1`		`@1 HILL (Heather)`
A11	`15`	`1`		`@1 WOLFF (Mark C.)`
A14	`01`			`@1 Group Health Research Institute and @3 USA @Z 1 aut.`
A14	`02`			`@1 University of Washington, Seattle @2 Washington, Maryland @3 USA @Z 5 aut.`
A14	`03`			`@1 Center for Vaccine Development, University of Maryland School of Medicine @2 Baltimore @3 USA @Z 2 aut. @Z 11 aut.`
A14	`04`			`@1 The EMMES Corporation @2 Rockville, Maryland @3 USA @Z 14 aut. @Z 15 aut.`
A14	`05`			`@1 University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System @2 Iowa City, Iowa @3 USA @Z 3 aut. @Z 8 aut.`
A14	`06`			`@1 Stanford University School of Medicine @2 Stanford, California @3 USA @Z 4 aut.`
A14	`07`			`@1 Cincinnati Children's Hospital Medical Center @2 Cincinnati, Ohio @3 USA @Z 6 aut.`
A14	`08`			`@1 Emory University School of Medicine @2 Atlanta, Georgia @3 USA @Z 7 aut. @Z 9 aut. @Z 10 aut. @Z 12 aut.`
A14	`09`			`@1 Southern Research Institute @2 Birmingham, Alabama @3 USA @Z 13 aut.`
A20				`@1 811-820`
A21				`@1 2012`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 2052 @5 354000509502200040`
A44				`@0 0000 @1 © 2012 INIST-CNRS. All rights reserved.`
A45				`@0 34 ref.`
A47	`01`	`1`		`@0 12-0371820`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 The Journal of infectious diseases`
A66	`01`			`@0 GBR`
C01	`01`		`ENG`	@0 Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.
C02	`01`	`X`		`@0 002A05C10`
C02	`02`	`X`		`@0 002B05`
C02	`03`	`X`		`@0 002A05F04`
C03	`01`	`X`	`FRE`	`@0 Virus grippal A @2 NW @5 01`
C03	`01`	`X`	`ENG`	`@0 Influenza A virus @2 NW @5 01`
C03	`01`	`X`	`SPA`	`@0 Influenza A virus @2 NW @5 01`
C03	`02`	`X`	`FRE`	`@0 Homme @5 02`
C03	`02`	`X`	`ENG`	`@0 Human @5 02`
C03	`02`	`X`	`SPA`	`@0 Hombre @5 02`
C03	`03`	`X`	`FRE`	`@0 Immunogénicité @5 05`
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C03	`03`	`X`	`SPA`	`@0 Inmunogenicidad @5 05`
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C03	`04`	`X`	`ENG`	`@0 Vaccine @5 06`
C03	`04`	`X`	`SPA`	`@0 Vacuna @5 06`
C03	`05`	`X`	`FRE`	`@0 Adjuvant immunologique @5 07`
C03	`05`	`X`	`ENG`	`@0 Immunological adjuvant @5 07`
C03	`05`	`X`	`SPA`	`@0 Coadyuvante inmunológico @5 07`
C03	`06`	`X`	`FRE`	`@0 Personne âgée @5 08`
C03	`06`	`X`	`ENG`	`@0 Elderly @5 08`
C03	`06`	`X`	`SPA`	`@0 Anciano @5 08`
C03	`07`	`X`	`FRE`	`@0 Infection @5 09`
C03	`07`	`X`	`ENG`	`@0 Infection @5 09`
C03	`07`	`X`	`SPA`	`@0 Infección @5 09`
C03	`08`	`X`	`FRE`	`@0 Grippe A @5 14`
C03	`08`	`X`	`ENG`	`@0 Influenza A @5 14`
C03	`08`	`X`	`SPA`	`@0 Gripe A @5 14`
C07	`01`	`X`	`FRE`	`@0 Influenzavirus A @2 NW`
C07	`01`	`X`	`ENG`	`@0 Influenzavirus A @2 NW`
C07	`01`	`X`	`SPA`	`@0 Influenzavirus A @2 NW`
C07	`02`	`X`	`FRE`	`@0 Orthomyxoviridae @2 NW`
C07	`02`	`X`	`ENG`	`@0 Orthomyxoviridae @2 NW`
C07	`02`	`X`	`SPA`	`@0 Orthomyxoviridae @2 NW`
C07	`03`	`X`	`FRE`	`@0 Virus @2 NW`
C07	`03`	`X`	`ENG`	`@0 Virus @2 NW`
C07	`03`	`X`	`SPA`	`@0 Virus @2 NW`
C07	`04`	`X`	`FRE`	`@0 Virose`
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C07	`04`	`X`	`SPA`	`@0 Virosis`
N21				`@1 289`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 12-0371820 INIST
ET :	Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons
AU :	JACKSON (Lisa A.); CHEN (Wilbur H.); STAPLETON (Jack T.); DEKKER (Cornelia L.); WALD (Anna); BRADY (Rebecca C.); EDUPUGANTI (Srilatha); WINOKUR (Patricia); MULLIGAN (Mark J.); KEYSERLING (Harry L.); KOTLOFF (Karen L.); ROUPHAEL (Nadine); NOAH (Diana L.); HILL (Heather); WOLFF (Mark C.)
AF :	Group Health Research Institute and/Etats-Unis (1 aut.); University of Washington, Seattle/Washington, Maryland/Etats-Unis (5 aut.); Center for Vaccine Development, University of Maryland School of Medicine/Baltimore/Etats-Unis (2 aut., 11 aut.); The EMMES Corporation/Rockville, Maryland/Etats-Unis (14 aut., 15 aut.); University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System/Iowa City, Iowa/Etats-Unis (3 aut., 8 aut.); Stanford University School of Medicine/Stanford, California/Etats-Unis (4 aut.); Cincinnati Children's Hospital Medical Center/Cincinnati, Ohio/Etats-Unis (6 aut.); Emory University School of Medicine/Atlanta, Georgia/Etats-Unis (7 aut., 9 aut., 10 aut., 12 aut.); Southern Research Institute/Birmingham, Alabama/Etats-Unis (13 aut.)
DT :	Publication en série; Niveau analytique
SO :	The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2012; Vol. 206; No. 6; Pp. 811-820; Bibl. 34 ref.
LA :	Anglais
EA :	Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.
CC :	002A05C10; 002B05; 002A05F04
FD :	Virus grippal A; Homme; Immunogénicité; Vaccin; Adjuvant immunologique; Personne âgée; Infection; Grippe A
FG :	Influenzavirus A; Orthomyxoviridae; Virus; Virose
ED :	Influenza A virus; Human; Immunogenicity; Vaccine; Immunological adjuvant; Elderly; Infection; Influenza A
EG :	Influenzavirus A; Orthomyxoviridae; Virus; Viral disease
SD :	Influenza A virus; Hombre; Inmunogenicidad; Vacuna; Coadyuvante inmunológico; Anciano; Infección; Gripe A
LO :	INIST-2052.354000509502200040
ID :	12-0371820

Links to Exploration step

Pascal:12-0371820

Le document en format XML

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<author><name sortKey="Keyserling, Harry L" sort="Keyserling, Harry L" uniqKey="Keyserling H" first="Harry L." last="Keyserling">Harry L. Keyserling</name>
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<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
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<author><name sortKey="Rouphael, Nadine" sort="Rouphael, Nadine" uniqKey="Rouphael N" first="Nadine" last="Rouphael">Nadine Rouphael</name>
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<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
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<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
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<author><name sortKey="Wolff, Mark C" sort="Wolff, Mark C" uniqKey="Wolff M" first="Mark C." last="Wolff">Mark C. Wolff</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons</title>
<author><name sortKey="Jackson, Lisa A" sort="Jackson, Lisa A" uniqKey="Jackson L" first="Lisa A." last="Jackson">Lisa A. Jackson</name>
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</affiliation>
</author>
<author><name sortKey="Chen, Wilbur H" sort="Chen, Wilbur H" uniqKey="Chen W" first="Wilbur H." last="Chen">Wilbur H. Chen</name>
<affiliation><inist:fA14 i1="03"><s1>Center for Vaccine Development, University of Maryland School of Medicine</s1>
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<author><name sortKey="Stapleton, Jack T" sort="Stapleton, Jack T" uniqKey="Stapleton J" first="Jack T." last="Stapleton">Jack T. Stapleton</name>
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<s2>Iowa City, Iowa</s2>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dekker, Cornelia L" sort="Dekker, Cornelia L" uniqKey="Dekker C" first="Cornelia L." last="Dekker">Cornelia L. Dekker</name>
<affiliation><inist:fA14 i1="06"><s1>Stanford University School of Medicine</s1>
<s2>Stanford, California</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<affiliation><inist:fA14 i1="02"><s1>University of Washington, Seattle</s1>
<s2>Washington, Maryland</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name>
<affiliation><inist:fA14 i1="07"><s1>Cincinnati Children's Hospital Medical Center</s1>
<s2>Cincinnati, Ohio</s2>
<s3>USA</s3>
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</affiliation>
</author>
<author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</name>
<affiliation><inist:fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
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<sZ>10 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Winokur, Patricia" sort="Winokur, Patricia" uniqKey="Winokur P" first="Patricia" last="Winokur">Patricia Winokur</name>
<affiliation><inist:fA14 i1="05"><s1>University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System</s1>
<s2>Iowa City, Iowa</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Mulligan, Mark J" sort="Mulligan, Mark J" uniqKey="Mulligan M" first="Mark J." last="Mulligan">Mark J. Mulligan</name>
<affiliation><inist:fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Keyserling, Harry L" sort="Keyserling, Harry L" uniqKey="Keyserling H" first="Harry L." last="Keyserling">Harry L. Keyserling</name>
<affiliation><inist:fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
<affiliation><inist:fA14 i1="03"><s1>Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rouphael, Nadine" sort="Rouphael, Nadine" uniqKey="Rouphael N" first="Nadine" last="Rouphael">Nadine Rouphael</name>
<affiliation><inist:fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
<affiliation><inist:fA14 i1="09"><s1>Southern Research Institute</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
<affiliation><inist:fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wolff, Mark C" sort="Wolff, Mark C" uniqKey="Wolff M" first="Mark C." last="Wolff">Mark C. Wolff</name>
<affiliation><inist:fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The Journal of infectious diseases</title>
<title level="j" type="abbreviated">J. infect. dis.</title>
<idno type="ISSN">0022-1899</idno>
<imprint><date when="2012">2012</date>
</imprint>
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<seriesStmt><title level="j" type="main">The Journal of infectious diseases</title>
<title level="j" type="abbreviated">J. infect. dis.</title>
<idno type="ISSN">0022-1899</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Elderly</term>
<term>Human</term>
<term>Immunogenicity</term>
<term>Immunological adjuvant</term>
<term>Infection</term>
<term>Influenza A</term>
<term>Influenza A virus</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Virus grippal A</term>
<term>Homme</term>
<term>Immunogénicité</term>
<term>Vaccin</term>
<term>Adjuvant immunologique</term>
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<front><div type="abstract" xml:lang="en">Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0022-1899</s0>
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<fA02 i1="01"><s0>JIDIAQ</s0>
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<fA03 i2="1"><s0>J. infect. dis.</s0>
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<fA06><s2>6</s2>
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<fA08 i1="01" i2="1" l="ENG"><s1>Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons</s1>
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<fA11 i1="01" i2="1"><s1>JACKSON (Lisa A.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>CHEN (Wilbur H.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>STAPLETON (Jack T.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>DEKKER (Cornelia L.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>WALD (Anna)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>BRADY (Rebecca C.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>EDUPUGANTI (Srilatha)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>WINOKUR (Patricia)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>MULLIGAN (Mark J.)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>KEYSERLING (Harry L.)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>KOTLOFF (Karen L.)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>ROUPHAEL (Nadine)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>NOAH (Diana L.)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>HILL (Heather)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>WOLFF (Mark C.)</s1>
</fA11>
<fA14 i1="01"><s1>Group Health Research Institute and</s1>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>University of Washington, Seattle</s1>
<s2>Washington, Maryland</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System</s1>
<s2>Iowa City, Iowa</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Stanford University School of Medicine</s1>
<s2>Stanford, California</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Cincinnati Children's Hospital Medical Center</s1>
<s2>Cincinnati, Ohio</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Southern Research Institute</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA20><s1>811-820</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
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<s2>2052</s2>
<s5>354000509502200040</s5>
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<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>34 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0371820</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>The Journal of infectious diseases</s0>
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<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002A05C10</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B05</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002A05F04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Virus grippal A</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
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<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Influenza A virus</s0>
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<s5>01</s5>
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<s5>02</s5>
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<s5>02</s5>
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<s5>02</s5>
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<s5>05</s5>
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<s5>05</s5>
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<fC03 i1="03" i2="X" l="SPA"><s0>Inmunogenicidad</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Vaccin</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Vaccine</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Vacuna</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Adjuvant immunologique</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Immunological adjuvant</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Coadyuvante inmunológico</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Personne âgée</s0>
<s5>08</s5>
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<fC03 i1="06" i2="X" l="ENG"><s0>Elderly</s0>
<s5>08</s5>
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<s5>09</s5>
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<s5>09</s5>
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<s5>09</s5>
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<s5>14</s5>
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<s5>14</s5>
</fC03>
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<s5>14</s5>
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<s2>NW</s2>
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<s2>NW</s2>
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<fC07 i1="01" i2="X" l="SPA"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
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<s2>NW</s2>
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<fC07 i1="02" i2="X" l="ENG"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
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<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Virose</s0>
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<fC07 i1="04" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fN21><s1>289</s1>
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<server><NO>PASCAL 12-0371820 INIST</NO>
<ET>Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons</ET>
<AU>JACKSON (Lisa A.); CHEN (Wilbur H.); STAPLETON (Jack T.); DEKKER (Cornelia L.); WALD (Anna); BRADY (Rebecca C.); EDUPUGANTI (Srilatha); WINOKUR (Patricia); MULLIGAN (Mark J.); KEYSERLING (Harry L.); KOTLOFF (Karen L.); ROUPHAEL (Nadine); NOAH (Diana L.); HILL (Heather); WOLFF (Mark C.)</AU>
<AF>Group Health Research Institute and/Etats-Unis (1 aut.); University of Washington, Seattle/Washington, Maryland/Etats-Unis (5 aut.); Center for Vaccine Development, University of Maryland School of Medicine/Baltimore/Etats-Unis (2 aut., 11 aut.); The EMMES Corporation/Rockville, Maryland/Etats-Unis (14 aut., 15 aut.); University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System/Iowa City, Iowa/Etats-Unis (3 aut., 8 aut.); Stanford University School of Medicine/Stanford, California/Etats-Unis (4 aut.); Cincinnati Children's Hospital Medical Center/Cincinnati, Ohio/Etats-Unis (6 aut.); Emory University School of Medicine/Atlanta, Georgia/Etats-Unis (7 aut., 9 aut., 10 aut., 12 aut.); Southern Research Institute/Birmingham, Alabama/Etats-Unis (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2012; Vol. 206; No. 6; Pp. 811-820; Bibl. 34 ref.</SO>
<LA>Anglais</LA>
<EA>Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</EA>
<CC>002A05C10; 002B05; 002A05F04</CC>
<FD>Virus grippal A; Homme; Immunogénicité; Vaccin; Adjuvant immunologique; Personne âgée; Infection; Grippe A</FD>
<FG>Influenzavirus A; Orthomyxoviridae; Virus; Virose</FG>
<ED>Influenza A virus; Human; Immunogenicity; Vaccine; Immunological adjuvant; Elderly; Infection; Influenza A</ED>
<EG>Influenzavirus A; Orthomyxoviridae; Virus; Viral disease</EG>
<SD>Influenza A virus; Hombre; Inmunogenicidad; Vacuna; Coadyuvante inmunológico; Anciano; Infección; Gripe A</SD>
<LO>INIST-2052.354000509502200040</LO>
<ID>12-0371820</ID>
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Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons

Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons

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