Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations

Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations
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DOI:
10.1016/j.vaccine.2008.08.058
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发表时间:
2008-11-05
期刊:
影响因子:
5.5
通讯作者:
Fehnle, K.
Fehnle, K.
中科院分区:
医学3区
文献类型:
--
作者:
Adam, D.;Fehnle, K.

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肺炎链球菌是儿童细菌性肺炎和其他呼吸道感染(RTI)的主要原因。七价结合肺炎球菌疫苗(PCV 7)为2岁以下儿童提供了一种有希望的预防肺炎球菌疾病的策略。在这项在德国进行的前瞻性流行病学研究中,2至6个月的儿童按照3:1的比例接受常规儿童疫苗联合接种,根据4剂方案,有或没有PCV 7。5984名儿童在加强剂量后1年可进行评估。根据德国指南,优先将有基础医学疾病的儿童纳入PCV 7组,因此PCV 7组中66%的儿童至少有一种医学风险因素,40%为早产,而对照组中分别为18%和6%。在这种不平衡的情况下,总体PCV 7使呼吸道感染减少了10.5%(95% CI:2.9-17.3%),临床诊断的肺炎减少了6.3%(95% CI:-15.9至23.7%)。在控制风险因素的倾向评分配对分析中,PCV 7对肺炎的有效性为24.8%(95% CI:0.9-43.1%)。在至少有一种医学菲斯克因素的儿童中,疫苗对肺炎的有效性为38.4%(95% CI:10.7-55.9%),而无风险因素的儿童为10.9%(95% CI:-20.2至33.9%)。在早产儿和足月儿中,当与广泛使用的六价常规疫苗组合同时施用时,PCV 7耐受性良好。结果表明,PCV 7对早产儿、儿童和合并症儿童的RTI安全有效,强调肺炎球菌结合疫苗在这些肺炎球菌疾病高风险儿童中的益处。(C)2008爱思唯尔有限公司保留所有权利。
Streptococcus pneumoniae is a major cause of bacterial pneumonia and other respiratory tract infections (RTI) in children. The heptavalent conjugated pneumococcal vaccine (PCV7) is offering a promising strategy against pneumococcal disease in children Younger than 2 years. In this prospective epidemiological study in Germany, children between 2 and 6 months of age received in a 3:1 ratio a routine childhood vaccine combination with or without PCV7 according to a four-dose schedule. Five thousand nine hundred and eighty-four children were evaluable 1 year after the booster dose. Due to German guidelines children with underlying medical conditions were preferentially included into the PCV7 group and hence 66% of the children in the PCV7 group had at least one medical risk factor and 40% were preterm born compared to 18% and 6% in the Control group. Overall PCV7 reduced respiratory tract infections by 10.5% (95% CI: 2.9-17.3%) and clinically diagnosed pneumonia by 6.3% (95% CI: -15.9 to 23.7%) in this unbalanced situation. In a propensity Score matched pair analysis controlling for risk factors, effectiveness of PCV7 against pneumonia was 24.8% (95% CI: 0.9-43.1%). In children with at least one medical Fisk factor vaccine effectiveness against pneumonia was 38.4% (95% CI: 10.7-55.9%) compared to 10.9% (95% CI: -20.2 to 33.9%) without a risk factor. In preterm and term born children, PCV7 was well tolerated when Simultaneously administered with widely used hexavalent routine vaccine combinations. The results demonstrate that PCV7 is safe and effective against RTI in preterm, children and in children with comorbidities stressing the benefit of pneumococcal conjugate vaccine in these children at high risk for pneumococcal disease. (C) 2008 Elsevier Ltd. All rights reserved.