Prescrire Int. 2011 Jan;20(112):5-7, 9.
The 7-valent pneumococcal conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) is the standard vaccine for the prevention of invasive pneumococcal infections in infants and children under 5 years of age. A 13-valent pneumococcal conjugate vaccine (with the addition of valences 1, 3, 5, 6A, 7F and 19A) has now been authorised to replace the 7-valent vaccine within the European Union. This new vaccine, adapted to recent epidemiological data on invasive pneumococcal infections, is supposed to cover at least 80% of pneumococcal infections in Europe. The protective potency of the 13-valent vaccine has not yet been tested in clinical trials. Clinical evaluation is based on two immunogenicity studies, in which the immunogenic potency of the 13-valent vaccine was similar to that of the 7-valent vaccine for their shared serotypes, but lower for serotypes 3, 6B and 9V. For these last two serotypes and for the new serotypes, the usual target antibody titre was reached after a booster injection. This was not the case for valence 3. * The vaccine used in immunogenicity studies did not contain polysorbate 80 (an excipient), and a non-inferiority study of the marketed vaccine containing polysorbate 80 was therefore conducted in 500 children. Non-inferiority was established for all 13 valences after the booster injection, but not for valences 6B and 23F after primary vaccination. According to the results of 10 studies, simultaneous administration of the 13-valent pneumococcal conjugate vaccine does not affect the immunogenicity of other vaccines generally administered before the age of 5 years. Other immunogenicity studies support the use of a variety of vaccine schedules for infants and children under 5 years of age who have not yet been vaccinated or who have started vaccination with the 7-valent vaccine. Increasing the number of valences in the vaccine from 7 to 13 led to no marked increase in local adverse effects (hypersensitivity, indurations, erythema) or systemic reactions (mainly fever, decreased sleep and irritability). In practice, replacing the 7-valent pneumococcal conjugate vaccine with the 13 valence vaccine could lead to a further reduction in the incidence of invasive pneumococcal infections. However, this remains to be confirmed by well-conducted epidemiological follow-up studies.
7价肺炎球菌结合疫苗（4、6B、9V、14、18C、19F、23F）是预防5岁以下婴幼儿侵袭性肺炎球菌感染的标准疫苗。一种13价肺炎球菌结合疫苗（增加了1、3、5、6A、7F和19A血清型）现已在欧盟获批，以取代7价疫苗。这种新疫苗根据侵袭性肺炎球菌感染的最新流行病学数据进行了调整，预计可覆盖欧洲至少80%的肺炎球菌感染。13价疫苗的保护效力尚未在临床试验中进行测试。临床评估基于两项免疫原性研究，其中13价疫苗对于其共有的血清型，免疫原效力与7价疫苗相似，但对于血清型3、6B和9V则较低。对于后两种血清型以及新血清型，在加强注射后达到了通常的目标抗体滴度。血清型3的情况并非如此。*免疫原性研究中使用的疫苗不含聚山梨酯80（一种辅料），因此在500名儿童中对含聚山梨酯80的市售疫苗进行了非劣效性研究。加强注射后，所有13个血清型均确立了非劣效性，但初次接种后血清型6B和23F未确立非劣效性。根据10项研究的结果，同时接种13价肺炎球菌结合疫苗不会影响通常在5岁前接种的其他疫苗的免疫原性。其他免疫原性研究支持对尚未接种疫苗或已开始接种7价疫苗的5岁以下婴幼儿采用多种疫苗接种程序。疫苗血清型数量从7种增加到13种，并未导致局部不良反应（超敏反应、硬结、红斑）或全身反应（主要是发热、睡眠减少和易激惹）明显增加。在实际应用中，用13价疫苗取代7价肺炎球菌结合疫苗可能会进一步降低侵袭性肺炎球菌感染的发病率。然而，这仍有待通过精心开展的流行病学随访研究加以证实。
