Whitney Cynthia G, Pilishvili Tamar, Farley Monica M, Schaffner William, Craig Allen S, Lynfield Ruth, Nyquist Ann-Christine, Gershman Kenneth A, Vazquez Marietta, Bennett Nancy M, Reingold Arthur, Thomas Ann, Glode Mary P, Zell Elizabeth R, Jorgensen James H, Beall Bernard, Schuchat Anne
Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Lancet. 2006 Oct 28;368(9546):1495-502. doi: 10.1016/S0140-6736(06)69637-2.
When seven-valent pneumococcal conjugate vaccine was introduced in the USA, many children were vaccinated on schedules that differed from those tested in clinical trials. Our aim was to assess the effectiveness of the vaccine against various pneumococcal serotypes, and to measure the effectiveness of the recommended dose schedule and of catch-up and incomplete schedules.
Invasive disease, defined as isolation of pneumococcus from a sterile site, was identified in children aged 3-59 months through the US Centers for Disease Control and Prevention's Active Bacterial Core surveillance. We tested isolates for serotype and antimicrobial susceptibility. Three controls, matched for age and zip code were selected for each case. We calculated the matched odds ratio for vaccination using conditional logistic regression, controlling for underlying conditions. Vaccine effectiveness was calculated as one minus the adjusted matched odds ratio times 100%.
We enrolled 782 cases and 2512 controls. Effectiveness of one or more doses against vaccine serotypes was 96% (95% CI 93-98) in healthy children and 81% (57-92) in those with coexisting disorders. It was 76% (63-85) against infections that were not susceptible to penicillin. Vaccination prevented disease caused by all seven vaccine serotypes, and by vaccine-related serotype 6A. Several schedules were more protective than no vaccination; three infant doses with a booster were more protective against vaccine-type disease than were three infant doses alone (p=0.0323).
The seven-valent pneumococcal conjugate vaccine prevents invasive disease in both healthy and chronically ill children. The vaccine is effective when used with various non-standard schedules.
在美国引入七价肺炎球菌结合疫苗时，许多儿童接种疫苗的时间表与临床试验中所测试的不同。我们的目的是评估该疫苗针对各种肺炎球菌血清型的有效性，并衡量推荐剂量时间表以及补种和未完成时间表的有效性。
通过美国疾病控制与预防中心的主动细菌核心监测，在3至59个月大的儿童中识别出侵袭性疾病，侵袭性疾病定义为从无菌部位分离出肺炎球菌。我们对分离株进行血清型和抗菌药敏测试。为每个病例选择三名年龄和邮政编码匹配的对照。我们使用条件逻辑回归计算接种疫苗的匹配比值比，并控制潜在条件。疫苗有效性计算为1减去调整后的匹配比值比乘以100%。
我们纳入了782例病例和2512名对照。一剂或多剂疫苗对健康儿童中疫苗血清型的有效性为96%（95%可信区间93 - 98），对患有合并症的儿童为81%（57 - 92）。对青霉素不敏感的感染，其有效性为76%（63 - 85）。接种疫苗预防了由所有七种疫苗血清型以及与疫苗相关的6A血清型引起的疾病。几种接种时间表比不接种更具保护作用；三剂婴儿疫苗加一剂加强针比仅三剂婴儿疫苗对疫苗型疾病的保护作用更强（p = 0.0323）。
七价肺炎球菌结合疫苗可预防健康儿童和慢性病儿童的侵袭性疾病。该疫苗在采用各种非标准接种时间表时均有效。
