美国FDA公布批准新疫苗Prevnar 13 (肺炎球菌13价结合疫苗) 英文药名: Prevnar (Pneumococcal 7-Valent Conjugate Vaccine) 中文药名: 7价肺炎球菌结合疫苗 生产厂家: Wyeth Ayerst Pharmaceuticals 批准日期：2010年2月 24日；公司: Wyeth Pharmaceuticals Inc. FDA的生物制品评价和研究中心执行主任Karen Midthun医学博士说：“尽管侵袭性肺炎球菌病发生率已急剧下降，在美国仍有儿童患这种严重疾患”。“Prevnar 13将有助于预防6种增加的血清型引起肺炎球菌疾病”。 一般描述： Prevnar 13，肺炎球菌13价结合疫苗(白喉CRM197蛋白)是一种消毒灭菌肺炎链球菌1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、和23F血清型荚膜抗原的糖类悬液，各自与无毒性白喉CRM197蛋白连接。每种血清型在大豆蛋白胨肉汤中生长。通过离心、沉淀、超滤、和柱层析各多糖类。多糖类在化学上被活化使糖类，通过还原氨化直接结合至至蛋白载体CRM197，形成复合糖(glycoconjugate)。CRM197是在酪蛋白氨基酸(casamino acids)和基于酵母萃取物介质中生长的白喉棒状杆菌(Corynebacterium diphtheria)株C7(197)培养液中分离的一种白喉毒素无毒性变种。通过超滤、硫酸铵沉淀、和离子交换层析纯化CRM197。The individual glycoconjugates are purified用超滤和柱层析纯化各种复合糖并分析糖类与蛋白比率，分子大小，游离糖类和游离蛋白。 制造商： 辉瑞实验室 药理分类： 圆环 活性成分（补）： 肺炎球菌13价结合疫苗（白喉CRM197蛋白）每0.5mL糖30.8micrograms;为IM已经来到的SUSP含铝。 指示（补）： 免疫接种对儿童的年龄6周造成侵袭性疾病的S.至5年（6岁生日前）因肺炎血清型1，3，4，5，第6A，6B，7楼，9伏，14，18C型，19A条，19F和23层，紧贴中耳炎由于血清型4，6B型，9伏，14，18C型，19F和23层。 药理作用： 接种Prevnar 13是13个血清型肺炎球菌结合到载体蛋白多糖白喉CRM197组成的疫苗。接种Prevnar 13包含同样的7种血清型肺炎链球菌接种Prevnar中发现，另外六个血清型（1，3，5，第6A，7楼，和19A）。 临床试验： 接种Prevnar 13人反对的侵入性肺炎球菌疾病的疗效推断，从一个随机，双盲，主动控制的非劣效在2个月相比，接种Prevnar 13的免疫原性的7价肺炎球菌结合疫苗，接种Prevnar大的婴儿的审判。为与肺炎球菌抗荚膜多糖IgG抗体浓度科目百分比非劣效标准≥0.35microgram/mL一个月之后的第三剂量为满足，为13个血清型的10个血清型6B型，9V的例外，和3 。虽然对血清型6B型和9V没有达到预先设定的标准响应，差异不大。抗体浓度，服药后四高比第三剂后取得的所有13个血清型。对肺炎球菌抗荚膜多糖的几何平均浓度非劣四剂后，符合标准是肺炎球菌血清型的13 12，但是不适合到3型反应。 法律分类： 接收 成人： 不推荐。 儿童： 每个剂量0.5mL到婴儿大腿前外侧或为幼儿和儿童三角肌的IM，避免神经和血管。五月预处理具有解热。 <六周：不推荐。 ≥六周：4剂通常给予2，4，6，和12-15个月的年龄（5月开始在6周龄：给第一三剂4-8周外，和至少2个月后，第四剂第三剂）。以前未接种的较大婴儿和儿童：年龄7-11个月：3剂量（第二剂量剂量一日后至少4周，剂量一周岁生日后第3和第2次剂量后至少2个月）; 12岁23个月：两剂除了至少2个月; 2岁5yrs：一剂一次。之前接种的接种Prevnar：5月完成4 - 13系列剂量接种Prevnar，如果系列是完成15个月，5年年龄：可能会收到一剂接种Prevnar 13日，至少8周后，接种Prevnar第四剂给予。 禁忌（补）： 白喉类毒素过敏的任何含疫苗。 警告/注意事项： 免疫力低下：可能获得最理想的反应。不能代替白喉，或23价肺炎球菌多糖疫苗接种。有交感肾上腺素可用。早产的婴儿。妊娠（Cat.C）。哺乳的母亲。 互动（补）： 免疫抑制剂：可能获得最理想的反应。 不良反应（补）： 注射液部位反应，发热，食欲下降，烦躁，增加或减少睡眠，嗜睡，腹泻，呕吐，皮疹，荨麻疹。 如何提供： 预填充注射器- 10 最后更新： 2010年8月2日 Manufacturer: Pfizer Labs Pharmacological Class: PCV Active Ingredient(s): Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) 30.8micrograms of saccharides per 0.5mL; susp for IM inj; contains aluminum. Indication(s): Immunization of children age 6 weeks to 5 years (before 6th birthday) against invasive disease caused by S. pneumoniae due to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and against otitis media due to serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Pharmacology: Prevnar 13 is a vaccine comprised of 13 pneumococcal serotype polysaccharides conjugated to the protein carrier diphtheria CRM197. Prevnar 13 contains the same seven S. pneumoniae serotypes found in Prevnar plus an additional six serotypes (1, 3, 5, 6A, 7F, and 19A). Clinical Trials: The efficacy of Prevnar 13 against invasive pneumococcal disease was inferred from a randomized, double-blind, active-controlled non-inferiority trial in 2-month old infants that compared the immunogenicity of Prevnar 13 to the 7-valent pneumococcal conjugate vaccine, Prevnar. The non-inferiority criterion for the percentage of subjects with pneumococcal anti-capsular polysaccharide IgG antibody concentrations ≥0.35microgram/mL one month after the third dose was met for 10 of the 13 serotypes, with the exception of serotypes 6B, 9V, and 3. Although the response to serotypes 6B and 9V did not meet the pre-specified criterion, the differences were marginal. Antibody concentrations after dose four were higher for all 13 serotypes than those achieved after the third dose. The non-inferiority criterion for pneumococcal anti-capsular polysaccharide geometric mean concentrations after four doses was met for 12 of the 13 pneumococcal serotypes, but was not met for the response to serotype 3. Legal Classification: Rx Adults: Not recommended. Children: Each dose is 0.5mL IM into the anterolateral thigh for infants or the deltoid muscle for toddlers and children; avoid nerves and blood vessels. May pretreat with antipyretic. <6weeks: not recommended. ≥6weeks: 4 doses usually given at 2, 4, 6, and 12–15 months of age (may start at 6 weeks of age: give 1st three doses 4–8 weeks apart, and 4th dose at least 2 months after 3rd dose). Previously unvaccinated older infants and children: 7–11 months of age: 3 doses (2nd dose at least 4 weeks after 1st dose, 3rd dose after 1st birthday and at least 2 months after 2nd dose); 12–23months of age: 2 doses at least 2 months apart; 2–5yrs of age: 1 dose once. Previously vaccinated with Prevnar: may complete 4-dose series with Prevnar 13; if series is completed and 15months–5years of age: may receive 1 dose of Prevnar 13, given at least 8 weeks after 4th dose of Prevnar. Contraindication(s): Allergies to any diphtheria toxoid-containing vaccine. Warnings/Precautions: Immunocompromised: may get suboptimal response. Not a substitute for diphtheria, or for 23-valent polysaccharide pneumococcal vaccinations. Have epinephrine inj available. Premature infants. Pregnancy (Cat.C). Nursing mothers. Interaction(s): Immunosuppressants: may get suboptimal response. Adverse Reaction(s): Inj site reactions, fever, decreased appetite, irritability, increased or decreased sleep, drowsiness, diarrhea, vomiting, rash, hives. How Supplied: Pre-filled syringe—10