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Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.

Identifieur interne : 001771 ( Main/Exploration ); précédent : 001770; suivant : 001772

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.

Auteurs : Edson D. Moreira [Brésil] ; Stan L. Block [États-Unis] ; Daron Ferris [Géorgie (pays)] ; Anna R. Giuliano [États-Unis] ; Ole-Erik Iversen [Norvège] ; Elmar A. Joura [Autriche] ; Pope Kosalaraksa [Thaïlande] ; Andrea Schilling [Chili] ; Pierre Van Damme [Belgique] ; Jacob Bornstein [Israël] ; F Xavier Bosch [Espagne] ; Sophie Pils [Autriche] ; Jack Cuzick [Royaume-Uni] ; Suzanne M. Garland [Australie] ; Warner Huh [États-Unis] ; Susanne K. Kjaer [Danemark] ; Hong Qi ; Donna Hyatt ; Jason Martin ; Erin Moeller ; Michael Ritter ; Martine Baudin [France] ; Alain Luxembourg

Source :

RBID : pubmed:27422279

Descripteurs français

English descriptors

Abstract

The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age.

DOI: 10.1542/peds.2015-4387
PubMed: 27422279


Affiliations:


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Le document en format XML

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<title xml:lang="en">Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.</title>
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<name sortKey="Moreira, Edson D" sort="Moreira, Edson D" uniqKey="Moreira E" first="Edson D" last="Moreira">Edson D. Moreira</name>
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<nlm:affiliation>Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br.</nlm:affiliation>
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<name sortKey="Block, Stan L" sort="Block, Stan L" uniqKey="Block S" first="Stan L" last="Block">Stan L. Block</name>
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<name sortKey="Schilling, Andrea" sort="Schilling, Andrea" uniqKey="Schilling A" first="Andrea" last="Schilling">Andrea Schilling</name>
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<name sortKey="Van Damme, Pierre" sort="Van Damme, Pierre" uniqKey="Van Damme P" first="Pierre" last="Van Damme">Pierre Van Damme</name>
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<name sortKey="Bornstein, Jacob" sort="Bornstein, Jacob" uniqKey="Bornstein J" first="Jacob" last="Bornstein">Jacob Bornstein</name>
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<name sortKey="Bosch, F Xavier" sort="Bosch, F Xavier" uniqKey="Bosch F" first="F Xavier" last="Bosch">F Xavier Bosch</name>
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<nlm:affiliation>Catalan Institute of Oncology/IDIBELL, Barcelona, Spain;</nlm:affiliation>
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<settlement type="city">Barcelone</settlement>
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<name sortKey="Pils, Sophie" sort="Pils, Sophie" uniqKey="Pils S" first="Sophie" last="Pils">Sophie Pils</name>
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<nlm:affiliation>Department of Obstetrics, Medical University of Vienna, Vienna, Austria;</nlm:affiliation>
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<wicri:regionArea>Department of Obstetrics, Medical University of Vienna, Vienna</wicri:regionArea>
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<settlement type="city">Vienne (Autriche)</settlement>
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<name sortKey="Cuzick, Jack" sort="Cuzick, Jack" uniqKey="Cuzick J" first="Jack" last="Cuzick">Jack Cuzick</name>
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<nlm:affiliation>Wolfson Institute of Preventive Medicine, London, United Kingdom;</nlm:affiliation>
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<wicri:regionArea>Wolfson Institute of Preventive Medicine, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
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<region type="région" nuts="1">Grand Londres</region>
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<name sortKey="Garland, Suzanne M" sort="Garland, Suzanne M" uniqKey="Garland S" first="Suzanne M" last="Garland">Suzanne M. Garland</name>
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<nlm:affiliation>Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia;</nlm:affiliation>
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<name sortKey="Huh, Warner" sort="Huh, Warner" uniqKey="Huh W" first="Warner" last="Huh">Warner Huh</name>
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<placeName>
<region type="state">Alabama</region>
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<wicri:cityArea>Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham</wicri:cityArea>
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<name sortKey="Kjaer, Susanne K" sort="Kjaer, Susanne K" uniqKey="Kjaer S" first="Susanne K" last="Kjaer">Susanne K. Kjaer</name>
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<nlm:affiliation>Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;</nlm:affiliation>
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<name sortKey="Qi, Hong" sort="Qi, Hong" uniqKey="Qi H" first="Hong" last="Qi">Hong Qi</name>
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<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
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<author>
<name sortKey="Hyatt, Donna" sort="Hyatt, Donna" uniqKey="Hyatt D" first="Donna" last="Hyatt">Donna Hyatt</name>
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<name sortKey="Martin, Jason" sort="Martin, Jason" uniqKey="Martin J" first="Jason" last="Martin">Jason Martin</name>
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<name sortKey="Moeller, Erin" sort="Moeller, Erin" uniqKey="Moeller E" first="Erin" last="Moeller">Erin Moeller</name>
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<author>
<name sortKey="Ritter, Michael" sort="Ritter, Michael" uniqKey="Ritter M" first="Michael" last="Ritter">Michael Ritter</name>
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</author>
<author>
<name sortKey="Baudin, Martine" sort="Baudin, Martine" uniqKey="Baudin M" first="Martine" last="Baudin">Martine Baudin</name>
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<nlm:affiliation>Sanofi Pasteur MSD, Lyon, France.</nlm:affiliation>
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<wicri:regionArea>Sanofi Pasteur MSD, Lyon</wicri:regionArea>
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<region type="region">Auvergne-Rhône-Alpes</region>
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</placeName>
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</author>
<author>
<name sortKey="Luxembourg, Alain" sort="Luxembourg, Alain" uniqKey="Luxembourg A" first="Alain" last="Luxembourg">Alain Luxembourg</name>
<affiliation>
<nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
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</analytic>
<series>
<title level="j">Pediatrics</title>
<idno type="eISSN">1098-4275</idno>
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<date when="2016" type="published">2016</date>
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<term>Adolescent</term>
<term>Adult</term>
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<term>Clinical Trials, Phase III as Topic</term>
<term>Edema (etiology)</term>
<term>Erythema (etiology)</term>
<term>Female</term>
<term>Fever (etiology)</term>
<term>Follow-Up Studies</term>
<term>Headache (etiology)</term>
<term>Humans</term>
<term>Immunization Schedule</term>
<term>Male</term>
<term>Outcome Assessment (Health Care)</term>
<term>Pain (etiology)</term>
<term>Papillomavirus Vaccines (administration & dosage)</term>
<term>Papillomavirus Vaccines (adverse effects)</term>
<term>Pregnancy</term>
<term>Pregnancy Complications (etiology)</term>
<term>Pregnancy Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Calendrier vaccinal</term>
<term>Complications de la grossesse (étiologie)</term>
<term>Céphalée (étiologie)</term>
<term>Douleur (étiologie)</term>
<term>Enfant</term>
<term>Essais cliniques de phase III comme sujet</term>
<term>Femelle</term>
<term>Fièvre (étiologie)</term>
<term>Grossesse</term>
<term>Humains</term>
<term>Issue de la grossesse</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Oedème (étiologie)</term>
<term>Vaccins contre les papillomavirus (administration et posologie)</term>
<term>Vaccins contre les papillomavirus (effets indésirables)</term>
<term>Érythème (étiologie)</term>
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</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Papillomavirus Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Papillomavirus Vaccines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Vaccins contre les papillomavirus</term>
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</keywords>
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<term>Edema</term>
<term>Erythema</term>
<term>Fever</term>
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<term>Pregnancy Complications</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr">
<term>Complications de la grossesse</term>
<term>Céphalée</term>
<term>Douleur</term>
<term>Fièvre</term>
<term>Oedème</term>
<term>Érythème</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Child</term>
<term>Clinical Trials, Phase III as Topic</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Immunization Schedule</term>
<term>Male</term>
<term>Outcome Assessment (Health Care)</term>
<term>Pregnancy</term>
<term>Pregnancy Outcome</term>
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</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Calendrier vaccinal</term>
<term>Enfant</term>
<term>Essais cliniques de phase III comme sujet</term>
<term>Femelle</term>
<term>Grossesse</term>
<term>Humains</term>
<term>Issue de la grossesse</term>
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<term>Mâle</term>
<term>Études de suivi</term>
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<front>
<div type="abstract" xml:lang="en">The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age.</div>
</front>
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