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首页> 外文期刊>Vaccine >Effectiveness of pneumococcal ce:italic>Haemophilus influenzae/ce:italic> protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial
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Effectiveness of pneumococcal ce:italic>Haemophilus influenzae/ce:italic> protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial

机译：肺炎球菌＆ Ce：斜体>嗜血杆菌的有效性：斜体>蛋白D缀合物对儿童肺炎的疫苗疫苗：群组随机试验

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BackgroundPneumococcal conjugate vaccines have potential to prevent significant proportion of childhood pneumonia. Finnish Invasive Pneumococcal disease vaccine trial was designed to assess the vaccine effectiveness (VE) of the 10-valent pneumococcalHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV10) against several outcomes. We now report results for pneumonia.MethodsIn this nationwide, cluster-randomised, double-blind trial, children younger than 19?months received PHiD-CV10 in 52 clusters or hepatitis vaccines as control in 26 clusters. Infants younger than 7?months at the first vaccination received either 3+1 or 2+1 vaccination schedule, children aged 7–11?months received 2+1, and those 12–18?months of age two-dose schedule. All hospitalizations and outpatient visits to hospital associated with ICD-10 codes compatible with pneumonia were identified through the National Care Register and 1–3 frontal chest X-ray images per event were collected. External readers who were unaware of the patients’ vaccination status retrospectively interpreted the images. The evaluated outcomes were hospital-diagnosed, hospital-treated pneumonia as primary diagnosis, and radiologically confirmed pneumonia during the blinded, intention-to-treat follow-up period from the first vaccination to the end of 2011. Total VE was calculated as 1 minus rate ratio of all pneumonia episodes.Results47 366 children were enrolled from February 2009, to October 2010. VE against all episodes of hospital-diagnosed pneumonia was 27% (95% confidence interval [CI]: 14%, 38%), 32% (95% CI: 3%, 52%), and 23% (95% CI: ?5%, 44%) in subjects enrolled at age 7, 7–11, and 12–18?months, respectively. Corresponding rate reductions were 3.4, 4.7, and 2.5 per 1000 person-years. VE estimates against pneumonia with alveolar consolidation or pleural effusion (WHO criteria) in the three cohorts were 45% (95% CI: 26%, 60%), 56% (95% CI: 14%, 77%), and 48% (95% CI: 2%, 73%), respectively.ConclusionPHiD-CV10 vaccination remarkably reduced disease burden due to pneumonia in infants and young children.Clinical trial registrationMain trial NCT00861380, nested carriage and otitis media trial NCT00839254 (ClinicalTrials.gov).
机译：BackgroundPneumococal缀合物疫苗有可能预防儿童肺炎的显着比例。芬兰侵袭性肺炎疾病疾病疫苗试验旨在评估10价肺炎球菌的疫苗效果（VE）对几种结果的10价蛋白D缀合物疫苗（PHID-CV10）。我们现在向Pneumonia的结果举报。本国全国，群集随机，双盲试验，儿童小于19？几个月，在52个簇或肝炎疫苗中获得Phid-CV10，如26个簇中的控制。婴儿在7岁以下的疫苗接种疫苗接种3 + 1或2 + 1个疫苗接种时间表，7-11岁的儿童收到2 + 1，以及那些12-18个月龄的两剂表。通过全国护理寄存器确定所有住院和与与肺炎相容的ICD-10代码相关的医院，每场比赛每次举办1-3个胸X射线图像。没有意识到患者疫苗接种状态的外部读者回顾性地解释了图像。评估的结果是医院诊断，医院治疗的肺炎作为初级诊断，并且在盲目的意向治疗后的肺炎肺炎，从第一次接种到2011年底的盲目的肺炎。总VE计算为1减1所有肺炎阶段的率比例。结果47 366 366儿童于2009年2月，2010年10月。反对所有医院诊断的肺炎发作的患者为27％（95％置信区间[CI]：14％，38％），32％ （95％CI：3％，52％）和23％（95％CI：？5％，44％）分别在年龄＆lt 7,7-11和12-18个月内注册。相应的速率减少为每1000人年3.4,4.7和2.5。三个队列中肺炎患有肺泡巩固或胸膜积液（WHO标准）的估计为45％（95％CI：26％，60％），56％（95％CI：14％，77％）和48％ （95％CI：2％，73％）分别。结论症-CV10疫苗接种，由于婴儿和幼儿肺炎，患有肺炎的疾病负担显着降低。临床试验登记域试验NCT00861380，嵌套托架和中耳炎媒体试验NCT00839254（Clinicaltrials.gov）。

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  • 来源
    《Vaccine》 |2018年第39期|共11页
  • 作者

    T.M. Kilpi; J. Jokinen; T. Puumalainen; H. Nieminen; E. Ruokokoski; H. Rinta-Kokko; M. Traskine; P. Lommel; M. Moreira; J. Ruiz-Guinazu; D. Borys; L. Schuerman; A.A. Palmu;

  • 作者单位

    Department of Health Protection National Institute for Health and Welfare;

    Department of Health Protection National Institute for Health and Welfare;

    Department of Health Protection National Institute for Health and Welfare;

    Department of Health Protection National Institute for Health and Welfare FinnMedi I;

    Department of Health Protection National Institute for Health and Welfare;

    Department of Health Protection National Institute for Health and Welfare;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Vaccine Research and Development GSK Parc de la Noire Epine;

    Department of Health Protection National Institute for Health and Welfare FinnMedi I;

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  • 中图分类 医学免疫学;
  • 关键词

    Vaccine effectiveness; Pneumococcus; Clinical trial; Pneumonia; Infant;

    机译：疫苗有效;肺炎球菌;临床试验;肺炎;婴儿;

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