a phase ii, randomized study on an investigational dtpw-hbvhib-menac conjugate vaccine administered to infants in northern ghana第二阶段,随机研究尚dtpw-hbvhib-menac结合疫苗接种对婴儿在加纳北部.pdfVIP
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a phase ii, randomized study on an investigational dtpw-hbvhib-menac conjugate vaccine administered to infants in northern ghana第二阶段,随机研究尚dtpw-hbvhib-menac结合疫苗接种对婴儿在加纳北部
A Phase II, Randomized Study on an Investigational
DTPw-HBV/Hib-MenAC Conjugate Vaccine Administered
to Infants in Northern Ghana
1 1 2 3 4
Abraham Hodgson , Abudulai Adams Forgor , Daniel Chandramohan , Zarifah Reed , Fred Binka ,
5 6 2
Cornelia Bevilacqua , Dominique Boutriau *, Brian Greenwood
1 Navrongo Health Research Centre, Ministry of Health, Navrongo, Ghana, 2 London School of Hygiene Tropical Medicine, London, United Kingdom, 3 World Health
Organization, Geneva, Switzerland, 4 University of Ghana, Accra, Ghana, 5 Consultant, Basel, Switzerland, 6 GlaxoSmithKline Biologicals, Rixensart, Belgium
Abstract
Background: Combining meningococcal vaccination with routine immunization in infancy may reduce the burden of
meningococcal meningitis, especially in the meningitis belt of Africa. We have evaluated the immunogenicity, persistence of
immune response, immune memory and safety of an investigational DTPw-HBV/Hib-MenAC conjugate vaccine given to
infants in Northern Ghana.
Methods and Findings: In this phase II, double blind, randomized, controlled study, 280 infants were primed with DTPw-
HBV/Hib-MenAC or DTPw-HBV/Hib vaccines at 6, 10 and 14 weeks of age. At 12 months of age, children in each group
received a challenge dose of serogroup A+C polysaccharides. Antibody responses were assessed pre, and one month-post
dose 3 of the priming schedule and pre and 1 month after administration of the challenge dose. One month post-dose 3,
87.8% and 88.2% of subjects in the study group had bactericidal meningococcal serogroup A (SBA-MenA) and
meningococcal serogroup C (SBA-MenC) antibo
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