Prescrire Int. 2002 Feb;11(57):7-10.
(1) Infants under two years of age are the children most exposed to invasive pneumococcal infections (meningitis and bacteraemia). The estimated incidence in France is about 45 cases per year per 100,000 in the first year of life. The 23-valent pneumococcal polysaccharide vaccine is ineffective in children under two years of age. (2) Marketing authorization has now been granted for a 7-valent pneumococcal conjugate vaccine for children under two years. It is the first pneumococcal vaccine specifically designed for this age group. (3) Its immunogenicity in 2 year old children has been carefully documented. (4) A comparative, randomised, double-blind trial involving nearly 38,000 Californian infants showed a lower incidence of both all invasive pneumococcal infections (approximately 1 case avoided per 400 children vaccinated), and those due to the 7 serotypes covered by the vaccine. (5) These results are not directly applicable to France, where the pneumococcal serotype distribution (especially the 7 serotypes covered by the vaccine) seems to be somewhat different, and where the incidence of invasive pneumococcal infections is much lower. (6) The 7-valent vaccine has not been assessed adequately in children who are at high risk for invasive pneumococcal infection. Some small studies of children with sickle-cell disease show adequate immunogenicity. (7) The known adverse effects of the 7-valent vaccine are acceptable, mainly comprising local reactions and fever. (8) The risk of an epidemiological shift towards serotypes not covered by the vaccine (through pharyngeal carriage and invasive infection) cannot been ruled out. In otitis media, an increase in pneumococcal infections due to serotypes not covered by the vaccine negates the benefit of vaccination. (9) In practice, considering the severity of invasive pneumococcal infections and the documented efficacy and safety of the 7-valent conjugate vaccine, vaccination is warranted for individual children under two years of age, especially those at risk, but epidemiological monitoring and pharmacovigilance must continue.
（1）两岁以下婴儿是最易感染侵袭性肺炎球菌感染（脑膜炎和菌血症）的儿童群体。法国一岁儿童侵袭性肺炎球菌感染的估计发病率约为每年每10万人45例。23价肺炎球菌多糖疫苗对两岁以下儿童无效。（2）目前已批准一种针对两岁以下儿童的7价肺炎球菌结合疫苗上市。这是首个专门为此年龄组设计的肺炎球菌疫苗。（3）已详细记录了该疫苗在两岁儿童中的免疫原性。（4）一项涉及近38000名加利福尼亚州婴儿的对照、随机、双盲试验表明，接种疫苗的儿童侵袭性肺炎球菌感染（每400名接种儿童中约避免1例感染）以及由疫苗覆盖的7种血清型引起的感染的发病率均有所降低。（5）这些结果不能直接应用于法国，因为法国的肺炎球菌血清型分布（尤其是疫苗覆盖的7种血清型）似乎有所不同，且侵袭性肺炎球菌感染的发病率要低得多。（6）7价疫苗在侵袭性肺炎球菌感染高危儿童中尚未得到充分评估。一些针对镰状细胞病患儿的小型研究显示其具有足够的免疫原性。（7）7价疫苗已知的不良反应是可以接受的，主要包括局部反应和发热。（8）不能排除出现血清型向疫苗未覆盖的血清型转变（通过咽部携带和侵袭性感染）的流行病学风险。在中耳炎方面，疫苗未覆盖血清型引起的肺炎球菌感染增加抵消了接种疫苗的益处。（9）实际上，鉴于侵袭性肺炎球菌感染的严重性以及7价结合疫苗已记录的疗效和安全性，有必要为两岁以下的个体儿童接种疫苗，尤其是那些高危儿童，但必须继续进行流行病学监测和药物警戒。
