Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children
Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children
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DOI：
10.1097/00006454-200003000-00003
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发表时间：
2000-03-01
影响因子：
3.6
通讯作者：
Edwards, K
中科院分区：
文献类型：
--
作者：
Black, S;Shinefield, H;Edwards, K
Objective.确定七价CRM 197肺炎球菌结合疫苗对疫苗血清型引起的侵袭性疾病的有效性、安全性和免疫原性，并确定该疫苗对中耳炎临床发作的有效性。在一项双盲试验中，对2、4、6和12至15个月大的婴儿接种了Wyeth Lederle七价CRM 197（PCV）; 37 868名儿童按1：1的比例随机分配接受肺炎球菌结合疫苗或C型脑膜炎球菌CRM 197结合疫苗。主要研究结果是疫苗血清型引起的侵袭性疾病。其他结局包括对侵袭性疾病的总体影响（不考虑血清型）、对临床中耳炎就诊和发作的有效性、对频繁和严重中耳炎的影响以及引流管放置。此外，在一项对自发性引流耳的分析中估计了对中耳炎的特定类型的有效性。在1998年8月的中期分析中，疫苗效力为100%的对照组中，17/17例完全接种疫苗的儿童和5/5例部分接种疫苗的儿童发生了疫苗血清型引起的侵袭性疾病。盲态病例确定持续至1999年4月。到那时为止，已经确定了40例完全接种疫苗的由疫苗血清型引起的侵袭性疾病病例，除1例对照外，其余均为97.4%的有效性（95%置信区间，82.7 - 99.9%），52例，除3例外均为对照组，疗效为93.9%（95%置信区间，79.6%至98.5%）。没有证据表明非疫苗血清型引起的疾病增加。对就诊、发作、频繁中耳炎和置管的有效率分别为8.9%、7.0%、9.3%和20.1%，P均< 0.04。在自发性引流耳的分析中，特定类型的有效率为66. 7%。这种七价肺炎球菌结合物似乎在预防幼儿侵袭性疾病方面非常有效，并对中耳炎有显著影响。
Objective. To determine the efficacy, safety and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media.Methods. The Wyeth Lederle Heptavalent CRM197 (PCV) was given to infants at 2, 4, 6 and 12 to 15 months of age in a double blind trial; 37 868 children were randomly assigned 1:1 to receive either the pneumococcal conjugate vaccine or meningococcus type C CRM197 conjugate. The primary study outcome was invasive disease caused by vaccine serotype. Other outcomes included overall impact on invasive disease regardless of serotype, effectiveness against clinical otitis media visits and episodes, impact against frequent and severe otitis media and ventilatory tube placement. In addition the serotype-specific efficacy against otitis media was estimated in an analysis of spontaneously draining ears.Results. In the interim analysis in August, 1998, 17 of the 17 cases of invasive disease caused by vaccine serotype in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Blinded case ascertainment was continued until April, 1999. As of that time 40 fully vaccinated eases of invasive disease caused by vaccine serotype had been identified, all but 1 in controls for an efficacy of 97.4% (95% confidence interval, 82.7 to 99.9%), and 52 cases, all but 3 in controls in the intent-to-treat analysis for an efficacy of 93.9% (95% confidence interval, 79.6 to 98.5%). There was no evidence of any increase of disease caused by nonvaccine serotypes. Efficacy for otitis media against visits, episodes, frequent otitis and ventilatory tube placement was 8.9, 7.0, 9.3 and 20.1% with P < 0.04 for all. In the analysis of spontaneously draining ears, serotype-specific effectiveness was 66.7%.Conclusion. This heptavalent pneumococcal conjugate appears to be highly effective in preventing invasive disease in young children and to have a significant impact on otitis media.