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一项评价 13 价肺炎球菌结合疫苗在≥65 岁老年人中与三价流感疫苗同时接种的免疫原性和安全性的随机、双盲临床试验。

A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years.

机构信息

Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany.

出版信息

Vaccine. 2011 Jul 18;29(32):5195-202. doi: 10.1016/j.vaccine.2011.05.031. Epub 2011 May 25.

Abstract

This randomized, double-blind study evaluated concomitant administration of 13-valent pneumococcal conjugate vaccine (PCV13) and trivalent inactivated influenza vaccine (TIV) in adults aged ≥65 years who were naïve to 23-valent pneumococcal polysaccharide vaccine. Patients (N=1160) were randomized 1:1 to receive PCV13+TIV followed by placebo, or Placebo+TIV followed by PCV13 at 0 and 1 months, with blood draws at 0, 1, and 2 months. Slightly lower pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G geometric mean concentrations were observed with PCV13+TIV relative to PCV13. Concomitant PCV13+TIV demonstrates acceptable immunogenicity and safety compared with either agent given alone.

摘要

这项随机、双盲研究评估了在首次接种 23 价肺炎球菌多糖疫苗的≥65 岁成人中,同时接种 13 价肺炎球菌结合疫苗(PCV13)和三价灭活流感疫苗(TIV)的效果。将 1160 名患者随机分为 1:1 组,分别在 0 和 1 个月时接受 PCV13+TIV 序贯安慰剂,或安慰剂+TIV 序贯 PCV13,在 0、1 和 2 个月时采血。与 PCV13 相比,PCV13+TIV 观察到的肺炎球菌血清型特异性荚膜多糖免疫球蛋白 G 几何平均浓度略低。与单独使用任一药物相比,同时使用 PCV13+TIV 具有可接受的免疫原性和安全性。

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