کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10968977 | 1102917 | 2011 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Influenza A (H1N1) 2009 two-dose immunization of US children: An observer-blinded, randomized, placebo-controlled trial
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کلمات کلیدی
GMTSAESRIDH1N1 - آنفلوانزای H1N1 Pandemic influenza - آنفولانزای همه گیرSingle radial immunodiffusion - ایمونوادفیوس تنها رادیالadverse event - عارضه جانبی یا عوارض جانبیhemagglutination inhibition - مهار هموگلوبینGeometric mean titer - میانگین میانگین هندسیhemagglutinin - هماگلوتینینVaccine - واکسنClinical trial - کارآزمایی بالینیhigh performance liquid chromatography - کروماتوگرافی مایع با کارایی بالاHPLC - کروماتوگرافی مایعی کاراChildren - کودکان
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The goal of this pediatric clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent inactivated pandemic (H1N1) 2009 vaccine in US children aged 6 months to 9 years of age. Randomized, observer-blinded, US multicenter phase 2 study assessing 2 doses of vaccine given 21 days apart in 474 children aged 6-35 months or 3-9 years. Children in each age group were randomly assigned to receive either a pandemic (H1N1) 2009 vaccine containing 7.5 or 15 μg of hemagglutinin (HA) or placebo in a 4:4:1 ratio. Primary outcome was hemagglutination inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitored throughout the study. The first dose of either A H1N1 vaccine formulation was more immunogenic in children older than 3 years than in younger children. 45-50% of children aged 6-35 months and 69-75% of children aged 3-9 year-old attained HI titers of â¥1:40. A second dose of A H1N1 vaccine further increased HI antibody responses with seroprotection and seroconversion rates reaching 90-99% in both age groups. Interestingly, the pandemic (H1N1) 2009 vaccine formulations elicited similar rates of solicited and unsolicited injection site and systemic reactions as the placebo. The data therefore demonstrate the high level immunogenicity in infants and children of an (H1N1) 2009 influenza vaccine displaying a safety and reactogenicity profile similar to placebo.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 29, Issue 8, 11 February 2011, Pages 1569-1575
Journal: Vaccine - Volume 29, Issue 8, 11 February 2011, Pages 1569-1575
نویسندگان
Eric Plennevaux, Mark Blatter, Matthew J. Cornish, Kerry Go, Daniel Kirby, Mostafa Wali, Mary-Kate Reeves-Hoché, Martine Denis,