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The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine

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dc.contributor.author Dbaibo G.
dc.contributor.author Van der Wielen M.
dc.contributor.author Reda M.
dc.contributor.author Medlej F.
dc.contributor.author Tabet C.
dc.contributor.author Boutriau D.
dc.contributor.author Sumbul A.
dc.contributor.author Anis S.
dc.contributor.author Miller J.M.
dc.contributor.editor
dc.date Aug-2012
dc.date.accessioned 2017-10-05T16:01:16Z
dc.date.available 2017-10-05T16:01:16Z
dc.date.issued 2012
dc.identifier 10.1016/j.ijid.2012.04.006
dc.identifier.isbn
dc.identifier.issn 12019712
dc.identifier.uri http://hdl.handle.net/10938/19405
dc.description.abstract Objectives: The immunogenicity and safety of the tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT) were evaluated in subjects previously vaccinated with a tetravalent meningococcal polysaccharide vaccine and in subjects without previous meningococcal vaccination. Methods: In this phase II, open, controlled study (NCT00661557), healthy subjects aged 4.5-34 years received one dose of MenACWY-TT at month 0. Subjects in the MPS group (n=192) had received polysaccharide vaccine in a study conducted 30-42 months earlier; age-matched subjects in the noMPS control group (n=79) had received no meningococcal vaccination within the past 10 years. Serum bactericidal activity using rabbit complement (rSBA) was measured at month 0 and month 1. Results: At month 1, ≥97.0percent of subjects had rSBA titers ≥1:128. Post-vaccination rSBA geometric mean titers (GMTs) were ≥3.9-fold higher than pre-vaccination in both treatment groups. Exploratory analyses showed no statistically significant differences between groups in percentages of subjects with rSBA titers ≥1:8 and ≥1:128, but significantly lower rSBA GMTs and vaccine response rates for each serogroup in the MPS versus the noMPS group. MenACWY-TT had an acceptable safety profile in both groups. Conclusions: These results suggest that MenACWY-TT could be used in vaccination programs irrespective of the pre-vaccination status with polysaccharide vaccine. © 2012 International Society for Infectious Diseases.
dc.format.extent
dc.language English
dc.publisher OXFORD
dc.relation.ispartof Publication Name: International Journal of Infectious Diseases; Publication Year: 2012; Volume: 16; no. 8;
dc.relation.ispartofseries
dc.relation.uri
dc.source Scopus
dc.subject.other
dc.title The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine
dc.type Article
dc.contributor.affiliation Dbaibo, G., Center for Infectious Diseases Research, American University of Beirut, PO Box 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon
dc.contributor.affiliation Van der Wielen, M., GlaxoSmithKline Biologicals, Wavre, Belgium
dc.contributor.affiliation Reda, M., Center for Infectious Diseases Research, American University of Beirut, PO Box 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon
dc.contributor.affiliation Medlej, F., Center for Infectious Diseases Research, American University of Beirut, PO Box 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon
dc.contributor.affiliation Tabet, C., Center for Infectious Diseases Research, American University of Beirut, PO Box 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon
dc.contributor.affiliation Boutriau, D., GlaxoSmithKline Biologicals, Wavre, Belgium
dc.contributor.affiliation Sumbul, A., GlaxoSmithKline Biologicals, Wavre, Belgium
dc.contributor.affiliation Anis, S., GlaxoSmithKline Pharmaceuticals, Dubai, United Arab Emirates
dc.contributor.affiliation Miller, J.M., GlaxoSmithKline Biologicals, King of Prussia, PA, United States
dc.contributor.authorAddress Dbaibo, G.; Center for Infectious Diseases Research, American University of Beirut, Po Box 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon; email: gdbaibo@aub.edu.lb
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.authorDivision
dc.contributor.authorEmail gdbaibo@aub.edu.lb
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Dbaibo, G
dc.contributor.authorInitials Van der Wielen, M
dc.contributor.authorInitials Reda, M
dc.contributor.authorInitials Medlej, F
dc.contributor.authorInitials Tabet, C
dc.contributor.authorInitials Boutriau, D
dc.contributor.authorInitials Sumbul, A
dc.contributor.authorInitials Anis, S
dc.contributor.authorInitials Miller, JM
dc.contributor.authorOrcidID
dc.contributor.authorReprintAddress Dbaibo, G (reprint author), Amer Univ Beirut, Ctr Infect Dis Res, POB 11-0236, Beirut 11072020, Lebanon.
dc.contributor.authorResearcherID
dc.contributor.authorUniversity American University of Beirut Medical Center
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dc.description.citedCount 8
dc.description.citedTotWOSCount 8
dc.description.citedWOSCount 8
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dc.identifier.articleNo
dc.identifier.coden IJIDF
dc.identifier.pubmedID 22704725
dc.identifier.scopusID 84864383952
dc.identifier.url
dc.publisher.address THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
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dc.relation.ispartofConferenceCode
dc.relation.ispartofConferenceDate
dc.relation.ispartofConferenceHosting
dc.relation.ispartofConferenceLoc
dc.relation.ispartofConferenceSponsor
dc.relation.ispartofConferenceTitle
dc.relation.ispartofFundingAgency
dc.relation.ispartOfISOAbbr Int. J. Infect. Dis.
dc.relation.ispartOfIssue 8
dc.relation.ispartOfPart
dc.relation.ispartofPubTitle International Journal of Infectious Diseases
dc.relation.ispartofPubTitleAbbr Int. J. Infect. Dis.
dc.relation.ispartOfSpecialIssue
dc.relation.ispartOfSuppl
dc.relation.ispartOfVolume 16
dc.source.ID WOS:000307124100006
dc.type.publication Journal
dc.subject.otherAuthKeyword Bactericidal activity
dc.subject.otherAuthKeyword Conjugate vaccine
dc.subject.otherAuthKeyword Hyporesponsiveness
dc.subject.otherAuthKeyword Polysaccharide vaccine
dc.subject.otherAuthKeyword Safety
dc.subject.otherAuthKeyword Tetravalent meningococcal vaccine
dc.subject.otherChemCAS tetanus toxoid, 57425-69-1, 93384-51-1
dc.subject.otherChemCAS Antibodies, Bacterial
dc.subject.otherChemCAS Immunotoxins
dc.subject.otherChemCAS Meningococcal Vaccines
dc.subject.otherChemCAS Polysaccharides, Bacterial
dc.subject.otherChemCAS Tetanus Toxoid
dc.subject.otherChemCAS Vaccines, Conjugate
dc.subject.otherChemCAS tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine
dc.subject.otherIndex Meningococcus vaccine
dc.subject.otherIndex polysaccharide vaccine
dc.subject.otherIndex tetanus toxoid
dc.subject.otherIndex adolescent
dc.subject.otherIndex adult
dc.subject.otherIndex antibody titer
dc.subject.otherIndex article
dc.subject.otherIndex bacterial strain
dc.subject.otherIndex child
dc.subject.otherIndex controlled study
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug safety
dc.subject.otherIndex fatigue
dc.subject.otherIndex female
dc.subject.otherIndex fever
dc.subject.otherIndex gastrointestinal symptom
dc.subject.otherIndex headache
dc.subject.otherIndex human
dc.subject.otherIndex immunogenicity
dc.subject.otherIndex injection site coloration
dc.subject.otherIndex injection site pain
dc.subject.otherIndex injection site swelling
dc.subject.otherIndex male
dc.subject.otherIndex medical record
dc.subject.otherIndex meningococcosis
dc.subject.otherIndex Neisseria meningitidis
dc.subject.otherIndex normal human
dc.subject.otherIndex phase 2 clinical trial
dc.subject.otherIndex serotype
dc.subject.otherIndex serum bactericidal activity
dc.subject.otherIndex skin redness
dc.subject.otherIndex Adolescent
dc.subject.otherIndex Adult
dc.subject.otherIndex Antibodies, Bacterial
dc.subject.otherIndex Child
dc.subject.otherIndex Child, Preschool
dc.subject.otherIndex Female
dc.subject.otherIndex Humans
dc.subject.otherIndex Immunization, Secondary
dc.subject.otherIndex Immunotoxins
dc.subject.otherIndex Male
dc.subject.otherIndex Meningitis, Meningococcal
dc.subject.otherIndex Meningococcal Vaccines
dc.subject.otherIndex Neisseria meningitidis
dc.subject.otherIndex Polysaccharides, Bacterial
dc.subject.otherIndex Tetanus Toxoid
dc.subject.otherIndex Vaccines, Conjugate
dc.subject.otherIndex Young Adult
dc.subject.otherKeywordPlus RANDOMIZED CONTROLLED-TRIAL
dc.subject.otherKeywordPlus LINKED-IMMUNOSORBENT-ASSAY
dc.subject.otherKeywordPlus ANTIBODY
dc.subject.otherKeywordPlus ADULTS
dc.subject.otherKeywordPlus ADOLESCENTS
dc.subject.otherKeywordPlus MEMORY
dc.subject.otherKeywordPlus HYPORESPONSIVENESS
dc.subject.otherKeywordPlus PREVENTION
dc.subject.otherKeywordPlus PROTECTION
dc.subject.otherKeywordPlus DIPHTHERIA
dc.subject.otherWOS Infectious Diseases


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