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Vaccine for prevention of mild and moderate-to-severe influenza in children

Show simple item record Jain V.K. Rivera L. Zaman K. Espos Jr. R.A. Sirivichayakul C. Quiambao B.P. Rivera-Medina D.M. Kerdpanich P. Ceyhan M. Dinleyici E.C. Cravioto A. Yunus M. Chanthavanich P. Limkittikul K. Kurugol Z. Alhan E. Caplanusi A. Durviaux S. Boute
dc.contributor.editor Dec-2013 2017-10-05T16:01:20Z 2017-10-05T16:01:20Z 2013
dc.identifier 10.1056/NEJMoa1215817
dc.identifier.issn 00284793
dc.description.abstract BACKGROUND: Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage. We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages. METHODS: In this multinational, phase 3, observer-blinded study, we randomly assigned children 3 to 8 years of age, in a 1:1 ratio, to receive the QIV or a hepatitis A vaccine (control). The primary end point was influenza A or B confirmed by real-time polymerase chain reaction (rt-PCR). Secondary end points were rt-PCR-confirmed, moderate-to-severe influenza and rt-PCR-positive, culture-confirmed influenza. The vaccine efficacy and the effect of vaccination on daily activities and utilization of health care resources were assessed in the total vaccinated cohort (2584 children in each group) and the per-protocol cohort (2379 children in the QIV group and 2398 in the control group). RESULTS: In the total vaccinated cohort, 62 children in the QIV group (2.40percent) and 148 in the control group (5.73percent) had rt-PCR-confirmed influenza, representing a QIV efficacy of 59.3percent (95percent confidence interval [CI], 45.2 to 69.7), with efficacy against culturecon-firmed influenza of 59.1percent (97.5percent CI, 41.2 to 71.5). For moderate-to-severe rt-PCR-confirmed influenza, the attack rate was 0.62percent (16 cases) in the QIV group and 2.36percent (61 cases) in the control group, representing a QIV efficacy of 74.2percent (97.5percent CI, 51.5 to 86.2). In the per-protocol cohort, the QIV efficacy was 55.4percent (95percent CI, 39.1 to 67.3), and the efficacy against culture-confirmed influenza 55.9percent (97.5percent CI, 35.4 to 69.9); the efficacy among children with moderate-to-severe influenza was 73.1percent (97.5percent CI, 47.1 to 86.3). The QIV was associated with reduced risks of a body temperature above 39°C and lower respiratory tract illness, as compared with the control vaccine, in the per-protocol cohort (relative risk, 0.29 [95percent CI, 0.16 to 0.56] and 0.20 [95percent CI, 0.04 to 0.92], respectively). The QIV was immunogenic against all four strains. Serious adverse events occurred in 36 children in the QIV group (1.4percent) and in 24 children in the control group (0.9percent). CONCLUSIONS: The QIV was efficacious in preventing influenza in children. Copyright © 2013 Massachusetts Medical Society.
dc.format.extent Pages: (2481-2491)
dc.language English
dc.publisher WALTHAM
dc.relation.ispartof Publication Name: New England Journal of Medicine; Publication Year: 2013; Volume: 369; no. 26; Pages: (2481-2491);
dc.source Scopus
dc.title Vaccine for prevention of mild and moderate-to-severe influenza in children
dc.type Article
dc.contributor.affiliation Jain, V.K., GlaxoSmithKline Vaccines, King of Prussia, PA, United States
dc.contributor.affiliation Rivera, L., Department of Neonatal-Perinatal Medicine, Hospital Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic
dc.contributor.affiliation Zaman, K., Centre for Child and Adolescent Health, International Center for Diarrheal Disease Research (ICDDR), Dhaka, Bangladesh
dc.contributor.affiliation Espos Jr., R.A., Department of Pediatrics, De la Salle Health Sciences Institute, De la Salle College of Medicine, Dasmarinas City, Philippines
dc.contributor.affiliation Sirivichayakul, C., Department of Tropical Pediatrics, Mahidol University, Bangkok, Thailand
dc.contributor.affiliation Quiambao, B.P., Clinical Research Division, Research Institute for Tropical Medicine, Muntinlupa City, Philippines
dc.contributor.affiliation Rivera-Medina, D.M., Clinical Research Department, Organización para el Desarrollo Y la Investigación Salud en Honduras (ODISH), Tegucigalpa, Honduras
dc.contributor.affiliation Kerdpanich, P., Department of Infectious Pediatrics, Phramongkutklao Hospital of the Royal Thai Army, Bangkok, Thailand
dc.contributor.affiliation Ceyhan, M., Department of Pediatrics and Infectious Diseases, Hacettepe University, Ankara, Turkey
dc.contributor.affiliation Dinleyici, E.C., Department of Pediatric Intensive Care and Infectious Disease Unit, Eskisehir Osmangazi University Faculty of Medicine, Eskisehir, Turkey
dc.contributor.affiliation Cravioto, A., Executive Director's Office, ICDDR, Dhaka, Bangladesh
dc.contributor.affiliation Yunus, M., Center for Child and Adolescent Health, ICDDR, Dhaka, Bangladesh
dc.contributor.affiliation Chanthavanich, P., Department of Tropical Pediatrics, Mahidol University, Bangkok, Thailand
dc.contributor.affiliation Limkittikul, K., Department of Tropical Pediatrics, Mahidol University, Bangkok, Thailand
dc.contributor.affiliation Kurugol, Z., Department of Pediatrics, Ege University Faculty of Medicine, Izmir, Turkey
dc.contributor.affiliation Alhan, E., Department of Pediatrics, Division of Pediatric Infectious Disease, Cukurova University, Adana, Turkey
dc.contributor.affiliation Caplanusi, A., GlaxoSmithKline Vaccines, Wavre, Belgium
dc.contributor.affiliation Durviaux, S., GlaxoSmithKline Vaccines, Wavre, Belgium
dc.contributor.affiliation Boutet, P., GlaxoSmithKline Vaccines, Wavre, Belgium
dc.contributor.affiliation Ofori-Anyinam, O., GlaxoSmithKline Vaccines, Wavre, Belgium
dc.contributor.affiliation Chandrasekaran, V., GlaxoSmithKline Vaccines, King of Prussia, PA, United States
dc.contributor.affiliation Dbaibo, G., Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Cairo St., Beirut 11-0236, Lebanon
dc.contributor.affiliation Innis, B.L., GlaxoSmithKline Vaccines, King of Prussia, PA, United States
dc.contributor.authorAddress Dbaibo, G.; Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Cairo St., Beirut 11-0236, Lebanon; email:
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Pediatrics and Adolescent Medicine;
dc.contributor.authorDepartment Pediatrics and Adolescent Medicine
dc.contributor.faculty Faculty of Medicine
dc.contributor.authorInitials Jain, VK
dc.contributor.authorInitials Rivera, L
dc.contributor.authorInitials Zaman, K
dc.contributor.authorInitials Espos, RA
dc.contributor.authorInitials Sirivichayakul, C
dc.contributor.authorInitials Quiambao, BP
dc.contributor.authorInitials Rivera-Medina, DM
dc.contributor.authorInitials Kerdpanich, P
dc.contributor.authorInitials Ceyhan, M
dc.contributor.authorInitials Dinleyici, EC
dc.contributor.authorInitials Cravioto, A
dc.contributor.authorInitials Yunus, M
dc.contributor.authorInitials Chanthavanich, P
dc.contributor.authorInitials Limkittikul, K
dc.contributor.authorInitials Kurugol, Z
dc.contributor.authorInitials Alhan, E
dc.contributor.authorInitials Caplanusi, A
dc.contributor.authorInitials Durviaux, S
dc.contributor.authorInitials Boutet, P
dc.contributor.authorInitials Ofo
dc.contributor.authorReprintAddress Dbaibo, G (reprint author), Amer Univ Beirut, Dept Pediat and Adolescent Med, Med Ctr, Rm C-649,Cairo St, Beirut 110236, Lebanon.
dc.contributor.authorUniversity American University of Beirut Medical Center
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dc.description.citedCount 4
dc.description.citedTotWOSCount 9
dc.description.citedWOSCount 9
dc.format.extentCount 11
dc.identifier.coden NEJMA
dc.identifier.pubmedID 24328444
dc.identifier.scopusID 84890902002
dc.publisher.address WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
dc.relation.ispartOfISOAbbr N. Engl. J. Med.
dc.relation.ispartOfIssue 26
dc.relation.ispartofPubTitle New England Journal of Medicine
dc.relation.ispartofPubTitleAbbr New Engl. J. Med.
dc.relation.ispartOfVolume 369
dc.source.ID WOS:000328863700006
dc.type.publication Journal
dc.subject.otherChemCAS Influenza Vaccines
dc.subject.otherChemCAS Vaccines, Inactivated
dc.subject.otherIndex hepatitis A vaccine
dc.subject.otherIndex influenza vaccine
dc.subject.otherIndex article
dc.subject.otherIndex body temperature
dc.subject.otherIndex bronchitis
dc.subject.otherIndex child
dc.subject.otherIndex clinical protocol
dc.subject.otherIndex cohort analysis
dc.subject.otherIndex controlled study
dc.subject.otherIndex convulsion
dc.subject.otherIndex disease association
dc.subject.otherIndex disease severity
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex female
dc.subject.otherIndex health care utilization
dc.subject.otherIndex human
dc.subject.otherIndex influenza
dc.subject.otherIndex influenza A
dc.subject.otherIndex influenza B
dc.subject.otherIndex influenza vaccination
dc.subject.otherIndex injection site erythema
dc.subject.otherIndex injection site pain
dc.subject.otherIndex injection site swelling
dc.subject.otherIndex lower respiratory tract infection
dc.subject.otherIndex male
dc.subject.otherIndex multicenter study
dc.subject.otherIndex nonhuman
dc.subject.otherIndex normal human
dc.subject.otherIndex phase 3 clinical trial (topic)
dc.subject.otherIndex polymerase chain reaction
dc.subject.otherIndex preschool child
dc.subject.otherIndex priority journal
dc.subject.otherIndex randomized controlled trial
dc.subject.otherIndex reverse transcription polymerase chain reaction
dc.subject.otherIndex school child
dc.subject.otherIndex single blind procedure
dc.subject.otherIndex unspecified side effect
dc.subject.otherIndex virus culture
dc.subject.otherIndex Child
dc.subject.otherIndex Child, Preschool
dc.subject.otherIndex Female
dc.subject.otherIndex Hemagglutination Inhibition Tests
dc.subject.otherIndex Humans
dc.subject.otherIndex Influenza A virus
dc.subject.otherIndex Influenza B virus
dc.subject.otherIndex Influenza Vaccines
dc.subject.otherIndex Influenza, Human
dc.subject.otherIndex Male
dc.subject.otherIndex Proportional Hazards Models
dc.subject.otherIndex Real-Time Polymerase Chain Reaction
dc.subject.otherIndex Severity of Illness Index
dc.subject.otherIndex Single-Blind Method
dc.subject.otherIndex Vaccines, Inactivated
dc.subject.otherKeywordPlus YOUNG-CHILDREN
dc.subject.otherKeywordPlus SEASONAL INFLUENZA
dc.subject.otherKeywordPlus B VIRUSES
dc.subject.otherKeywordPlus EFFICACY
dc.subject.otherKeywordPlus TRIAL
dc.subject.otherKeywordPlus PCR
dc.subject.otherKeywordPlus IMMUNIZATION
dc.subject.otherKeywordPlus INFECTION
dc.subject.otherKeywordPlus RESPONSES
dc.subject.otherKeywordPlus INFANTS
dc.subject.otherWOS Medicine, General and Internal

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