Sanofi Pasteur, France.
Vaccine. 2013 Feb 18;31(9):1255-8. doi: 10.1016/j.vaccine.2012.11.087. Epub 2012 Dec 12.
The immunogenicity of a primary series of a new, fully liquid DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim), administered at 2, 4, 6 months of age in four clinical studies is reviewed. Immunogenicity data at 1 month after the third vaccination were assessed and pooled from a total of 1270 participants (per-protocol population) in four randomized clinical trials in Argentina, Mexico, and Peru. Hepatitis B vaccine was not administered at birth. All seroprotection (D, T, polio-1, -2, -3, Hep B, PRP-T [Hib]), seroconversion (PT and FHA), and vaccine response (PT and FHA) data were high, and were similar to licensed comparators (pooled SP, SC, and VR rates were 97.1-100%, 96.0-97.0%, and 99.7-99.9%, respectively). These data show the good immunogenicity of this new hexavalent vaccine that can provide the opportunity to increase global compliance to complex pediatric vaccination schedules.
新的全液体型无细胞百白破-脊灰灭活-乙肝-结合型 Hib 疫苗(Hexaxim)在 2、4、6 月龄进行基础免疫的免疫原性,在四项临床研究中进行了评估。共有来自阿根廷、墨西哥和秘鲁的四项随机临床试验的 1270 名(符合方案人群)参与者在第三针接种后 1 个月时评估了免疫原性数据。乙肝疫苗未在出生时接种。所有血清保护率(D、T、脊灰-1、-2、-3、乙肝、PRP-T[Hib])、血清转化率(PT 和 FHA)和疫苗应答率(PT 和 FHA)均较高,且与已上市的同类疫苗相当(血清保护率、血清转化率和疫苗效力的合并率分别为 97.1%-100%、96.0%-97.0%和 99.7%-99.9%)。这些数据表明,这种新的六价疫苗具有良好的免疫原性,可提高全球对复杂儿童疫苗接种计划的依从性。