Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.
Identifieur interne : 001714 ( PubMed/Checkpoint ); précédent : 001713; suivant : 001715Safety 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 LuxembourgSource :
- Pediatrics [ 1098-4275 ] ; 2016.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Calendrier vaccinal, Complications de la grossesse (étiologie), Céphalée (étiologie), Douleur (étiologie), Enfant, Essais cliniques de phase III comme sujet, Femelle, Fièvre (étiologie), Grossesse, Humains, Issue de la grossesse, Jeune adulte, Mâle, Oedème (étiologie), Vaccins contre les papillomavirus (administration et posologie), Vaccins contre les papillomavirus (effets indésirables), Érythème (étiologie), Études de suivi, Évaluation de résultat (soins).
- MESH :
- administration et posologie : Vaccins contre les papillomavirus.
- effets indésirables : Vaccins contre les papillomavirus.
- étiologie : Complications de la grossesse, Céphalée, Douleur, Fièvre, Oedème, Érythème.
- Adolescent, Adulte, Calendrier vaccinal, Enfant, Essais cliniques de phase III comme sujet, Femelle, Grossesse, Humains, Issue de la grossesse, Jeune adulte, Mâle, Études de suivi, Évaluation de résultat (soins).
English descriptors
- KwdEn :
- Adolescent, Adult, Child, Clinical Trials, Phase III as Topic, Edema (etiology), Erythema (etiology), Female, Fever (etiology), Follow-Up Studies, Headache (etiology), Humans, Immunization Schedule, Male, Outcome Assessment (Health Care), Pain (etiology), Papillomavirus Vaccines (administration & dosage), Papillomavirus Vaccines (adverse effects), Pregnancy, Pregnancy Complications (etiology), Pregnancy Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Papillomavirus Vaccines.
- chemical , adverse effects : Papillomavirus Vaccines.
- etiology : Edema, Erythema, Fever, Headache, Pain, Pregnancy Complications.
- Adolescent, Adult, Child, Clinical Trials, Phase III as Topic, Female, Follow-Up Studies, Humans, Immunization Schedule, Male, Outcome Assessment (Health Care), Pregnancy, Pregnancy Outcome, Young Adult.
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:
- Australie, Autriche, Belgique, Brésil, Chili, Danemark, Espagne, France, Géorgie (pays), Israël, Norvège, Royaume-Uni, Thaïlande, États-Unis
- Alabama, Angleterre, Auvergne-Rhône-Alpes, Bahia, Catalogne, Floride, Grand Londres, Hovedstaden, Kentucky, Province d'Anvers, Rhône-Alpes, Région flamande, Vienne (Autriche)
- Anvers, Barcelone, Copenhague, Londres, Lyon, Vienne (Autriche)
- Université d'Anvers
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:27422279Le document en format XML
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<author><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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<sourceDesc><biblStruct><analytic><title xml:lang="en">Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.</title>
<author><name sortKey="Moreira, Edson D" sort="Moreira, Edson D" uniqKey="Moreira E" first="Edson D" last="Moreira">Edson D. Moreira</name>
<affiliation wicri:level="2"><nlm:affiliation>Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br.</nlm:affiliation>
<country wicri:rule="url">Brésil</country>
<wicri:regionArea>Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia</wicri:regionArea>
<placeName><region type="state">Bahia</region>
</placeName>
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<author><name sortKey="Block, Stan L" sort="Block, Stan L" uniqKey="Block S" first="Stan L" last="Block">Stan L. Block</name>
<affiliation wicri:level="2"><nlm:affiliation>Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky;</nlm:affiliation>
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<author><name sortKey="Ferris, Daron" sort="Ferris, Daron" uniqKey="Ferris D" first="Daron" last="Ferris">Daron Ferris</name>
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<author><name sortKey="Giuliano, Anna R" sort="Giuliano, Anna R" uniqKey="Giuliano A" first="Anna R" last="Giuliano">Anna R. Giuliano</name>
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<author><name sortKey="Iversen, Ole Erik" sort="Iversen, Ole Erik" uniqKey="Iversen O" first="Ole-Erik" last="Iversen">Ole-Erik Iversen</name>
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<author><name sortKey="Joura, Elmar A" sort="Joura, Elmar A" uniqKey="Joura E" first="Elmar A" last="Joura">Elmar A. Joura</name>
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<author><name sortKey="Kosalaraksa, Pope" sort="Kosalaraksa, Pope" uniqKey="Kosalaraksa P" first="Pope" last="Kosalaraksa">Pope Kosalaraksa</name>
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<author><name sortKey="Schilling, Andrea" sort="Schilling, Andrea" uniqKey="Schilling A" first="Andrea" last="Schilling">Andrea Schilling</name>
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<country xml:lang="fr">Chili</country>
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<author><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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<author><name sortKey="Bornstein, Jacob" sort="Bornstein, Jacob" uniqKey="Bornstein J" first="Jacob" last="Bornstein">Jacob Bornstein</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel;</nlm:affiliation>
<country xml:lang="fr">Israël</country>
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<author><name sortKey="Bosch, F Xavier" sort="Bosch, F Xavier" uniqKey="Bosch F" first="F Xavier" last="Bosch">F Xavier Bosch</name>
<affiliation wicri:level="3"><nlm:affiliation>Catalan Institute of Oncology/IDIBELL, Barcelona, Spain;</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Catalan Institute of Oncology/IDIBELL, Barcelona</wicri:regionArea>
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<author><name sortKey="Pils, Sophie" sort="Pils, Sophie" uniqKey="Pils S" first="Sophie" last="Pils">Sophie Pils</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Obstetrics, Medical University of Vienna, Vienna, Austria;</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Obstetrics, Medical University of Vienna, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
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<author><name sortKey="Cuzick, Jack" sort="Cuzick, Jack" uniqKey="Cuzick J" first="Jack" last="Cuzick">Jack Cuzick</name>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Wolfson Institute of Preventive Medicine, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Garland, Suzanne M" sort="Garland, Suzanne M" uniqKey="Garland S" first="Suzanne M" last="Garland">Suzanne M. Garland</name>
<affiliation wicri:level="1"><nlm:affiliation>Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia;</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville</wicri:regionArea>
<wicri:noRegion>Parkville</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Huh, Warner" sort="Huh, Warner" uniqKey="Huh W" first="Warner" last="Huh">Warner Huh</name>
<affiliation wicri:level="2"><nlm:affiliation>Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Alabama</region>
</placeName>
<wicri:cityArea>Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Kjaer, Susanne K" sort="Kjaer, Susanne K" uniqKey="Kjaer S" first="Susanne K" last="Kjaer">Susanne K. Kjaer</name>
<affiliation wicri:level="3"><nlm:affiliation>Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Qi, Hong" sort="Qi, Hong" uniqKey="Qi H" first="Hong" last="Qi">Hong Qi</name>
<affiliation><nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hyatt, Donna" sort="Hyatt, Donna" uniqKey="Hyatt D" first="Donna" last="Hyatt">Donna Hyatt</name>
<affiliation><nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Martin, Jason" sort="Martin, Jason" uniqKey="Martin J" first="Jason" last="Martin">Jason Martin</name>
<affiliation><nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Moeller, Erin" sort="Moeller, Erin" uniqKey="Moeller E" first="Erin" last="Moeller">Erin Moeller</name>
<affiliation><nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Ritter, Michael" sort="Ritter, Michael" uniqKey="Ritter M" first="Michael" last="Ritter">Michael Ritter</name>
<affiliation><nlm:affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</nlm:affiliation>
<wicri:noCountry code="subField">New Jersey; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Baudin, Martine" sort="Baudin, Martine" uniqKey="Baudin M" first="Martine" last="Baudin">Martine Baudin</name>
<affiliation wicri:level="3"><nlm:affiliation>Sanofi Pasteur MSD, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Sanofi Pasteur MSD, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</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>
</affiliation>
</author>
</analytic>
<series><title level="j">Pediatrics</title>
<idno type="eISSN">1098-4275</idno>
<imprint><date when="2016" type="published">2016</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Child</term>
<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>
<term>Études de suivi</term>
<term>Évaluation de résultat (soins)</term>
</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>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins contre les papillomavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Edema</term>
<term>Erythema</term>
<term>Fever</term>
<term>Headache</term>
<term>Pain</term>
<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>
<term>Young Adult</term>
</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>
<term>Jeune adulte</term>
<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>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27422279</PMID>
<DateCreated><Year>2016</Year>
<Month>08</Month>
<Day>02</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>06</Month>
<Day>15</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>06</Month>
<Day>15</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1098-4275</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>138</Volume>
<Issue>2</Issue>
<PubDate><Year>2016</Year>
<Month>Aug</Month>
</PubDate>
</JournalIssue>
<Title>Pediatrics</Title>
<ISOAbbreviation>Pediatrics</ISOAbbreviation>
</Journal>
<ArticleTitle>Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.</ArticleTitle>
<ELocationID EIdType="doi" ValidYN="Y">10.1542/peds.2015-4387</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">e20154387</ELocationID>
<Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination.</AbstractText>
<CopyrightInformation>Copyright © 2016 by the American Academy of Pediatrics.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Moreira</LastName>
<ForeName>Edson D</ForeName>
<Initials>ED</Initials>
<Suffix>Jr</Suffix>
<AffiliationInfo><Affiliation>Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Block</LastName>
<ForeName>Stan L</ForeName>
<Initials>SL</Initials>
<AffiliationInfo><Affiliation>Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ferris</LastName>
<ForeName>Daron</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Giuliano</LastName>
<ForeName>Anna R</ForeName>
<Initials>AR</Initials>
<AffiliationInfo><Affiliation>Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, Florida;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Iversen</LastName>
<ForeName>Ole-Erik</ForeName>
<Initials>OE</Initials>
<AffiliationInfo><Affiliation>Department of Gynaecology, University of Bergen, Bergen, Norway;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Joura</LastName>
<ForeName>Elmar A</ForeName>
<Initials>EA</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics, Medical University of Vienna, Vienna, Austria;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kosalaraksa</LastName>
<ForeName>Pope</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Khon Kaen University, Khon Kaen, Thailand;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schilling</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Departamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana-Universidad Del Desarrollo, Santiago, Chile;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Van Damme</LastName>
<ForeName>Pierre</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bornstein</LastName>
<ForeName>Jacob</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bosch</LastName>
<ForeName>F Xavier</ForeName>
<Initials>FX</Initials>
<AffiliationInfo><Affiliation>Catalan Institute of Oncology/IDIBELL, Barcelona, Spain;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pils</LastName>
<ForeName>Sophie</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics, Medical University of Vienna, Vienna, Austria;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cuzick</LastName>
<ForeName>Jack</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Wolfson Institute of Preventive Medicine, London, United Kingdom;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Garland</LastName>
<ForeName>Suzanne M</ForeName>
<Initials>SM</Initials>
<AffiliationInfo><Affiliation>Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Huh</LastName>
<ForeName>Warner</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kjaer</LastName>
<ForeName>Susanne K</ForeName>
<Initials>SK</Initials>
<AffiliationInfo><Affiliation>Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Qi</LastName>
<ForeName>Hong</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hyatt</LastName>
<ForeName>Donna</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Martin</LastName>
<ForeName>Jason</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moeller</LastName>
<ForeName>Erin</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ritter</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Baudin</LastName>
<ForeName>Martine</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Sanofi Pasteur MSD, Lyon, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Luxembourg</LastName>
<ForeName>Alain</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, New Jersey; and.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D017418">Meta-Analysis</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>07</Month>
<Day>15</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Pediatrics</MedlineTA>
<NlmUniqueID>0376422</NlmUniqueID>
<ISSNLinking>0031-4005</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D053918">Papillomavirus Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>AIM</CitationSubset>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017326" MajorTopicYN="N">Clinical Trials, Phase III as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004487" MajorTopicYN="N">Edema</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004890" MajorTopicYN="N">Erythema</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005334" MajorTopicYN="N">Fever</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006261" MajorTopicYN="N">Headache</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007115" MajorTopicYN="N">Immunization Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017063" MajorTopicYN="N">Outcome Assessment (Health Care)</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010146" MajorTopicYN="N">Pain</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D053918" MajorTopicYN="N">Papillomavirus Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011248" MajorTopicYN="N">Pregnancy Complications</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011256" MajorTopicYN="N">Pregnancy Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>05</Month>
<Day>12</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>7</Month>
<Day>17</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>7</Month>
<Day>17</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>6</Month>
<Day>16</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">27422279</ArticleId>
<ArticleId IdType="pii">peds.2015-4387</ArticleId>
<ArticleId IdType="doi">10.1542/peds.2015-4387</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Brésil</li>
<li>Chili</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Géorgie (pays)</li>
<li>Israël</li>
<li>Norvège</li>
<li>Royaume-Uni</li>
<li>Thaïlande</li>
<li>États-Unis</li>
</country>
<region><li>Alabama</li>
<li>Angleterre</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Bahia</li>
<li>Catalogne</li>
<li>Floride</li>
<li>Grand Londres</li>
<li>Hovedstaden</li>
<li>Kentucky</li>
<li>Province d'Anvers</li>
<li>Rhône-Alpes</li>
<li>Région flamande</li>
<li>Vienne (Autriche)</li>
</region>
<settlement><li>Anvers</li>
<li>Barcelone</li>
<li>Copenhague</li>
<li>Londres</li>
<li>Lyon</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName><li>Université d'Anvers</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Hyatt, Donna" sort="Hyatt, Donna" uniqKey="Hyatt D" first="Donna" last="Hyatt">Donna Hyatt</name>
<name sortKey="Luxembourg, Alain" sort="Luxembourg, Alain" uniqKey="Luxembourg A" first="Alain" last="Luxembourg">Alain Luxembourg</name>
<name sortKey="Martin, Jason" sort="Martin, Jason" uniqKey="Martin J" first="Jason" last="Martin">Jason Martin</name>
<name sortKey="Moeller, Erin" sort="Moeller, Erin" uniqKey="Moeller E" first="Erin" last="Moeller">Erin Moeller</name>
<name sortKey="Qi, Hong" sort="Qi, Hong" uniqKey="Qi H" first="Hong" last="Qi">Hong Qi</name>
<name sortKey="Ritter, Michael" sort="Ritter, Michael" uniqKey="Ritter M" first="Michael" last="Ritter">Michael Ritter</name>
</noCountry>
<country name="Brésil"><region name="Bahia"><name sortKey="Moreira, Edson D" sort="Moreira, Edson D" uniqKey="Moreira E" first="Edson D" last="Moreira">Edson D. Moreira</name>
</region>
</country>
<country name="États-Unis"><region name="Kentucky"><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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