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Menveo (Meningococcal (Groups A, C, Y and W-135)脑膜炎球菌结合疫苗
制造商：
诺华制药公司
类药物：
疫苗的研制。
活性成分（补）：
脑膜炎奈瑟菌寡糖结合疫苗（白喉CRM197蛋白棒状杆菌）; +5micrograms A组C组，Y和的W - 135 + 32.7 -白喉CRM197蛋白64.1micrograms每个10micrograms;每0.5mL时，即时消息已经来到冻干重组后的密码;不含防腐剂。
适应症（补）：
脑膜炎免疫接种。
Manufacturer:
Novartis Pharmaceuticals Corp
Pharmacological Class:
Vaccine.
Active Ingredient(s):
Neisseria meningitidis oligosaccharide conjugate vaccine (Corynebacterium diphtheriae CRM197 protein); 10micrograms of Group A + 5micrograms each of Group C, Y, and W-135 + 32.7–64.1micrograms of diphtheria CRM197 protein; per 0.5mL; lyophilized pwd for IM inj after reconstitution; preservative-free.
Indication(s):
Meningitis immunization.
Pharmacology:
Menveo is a quadrivalent meningococcal conjugate vaccine that prevents invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Vaccination with Menveo induces the production of bactericidal antibodies specific to the capsular polysaccharides of the indicated serogroups.
Clinical Trials:
The efficacy of Menveo has been inferred from the demonstration of non-inferiority of the serum bactericidal antibody responses to those of Menactra (from Sanofi Pasteur) among patients (11–55 years of age). Serogroup-specific anticapsular antibodies with bactericidal activity were measured using pooled human serum that lacked bactericidal activity as the source of exogenous complement (hSBA). Immunogenicity was evaluated in a randomized, multicenter, active controlled trial involving 3539 participants, who were randomized to receive either Menveo (N=2663) or Menactra (N=876). The primary effectiveness endpoints of the study were hSBA seroresponse rates to each serogroup 28 days after vaccination. Seroresponse was defined as: for subjects with a pre-vaccination hSBA titer of <1:4, a post vaccination titer of ≥1:8 and among subjects with a pre-vaccination hSBA titer of ≥1:4, a post vaccination titer at least 4-fold higher than baseline.
In study patients aged 11–18 years, non-inferiority of Menveo to Menactra was demonstrated for all four serogroups using the primary endpoint (hSBA seroresponse). The percentages of subjects with hSBA seroresponse were statistically higher for serogroups A, W, and Y in the Menveo group, as compared to the Menactra group.
In study patients aged 19–55 years, non-inferiority of Menveo to Menactra was demonstrated for all four serogroups also using the hSBA seroresponse. The percentage of subjects with hSBA seroresponse was statistically higher for serogroups C, W, and Y in the Menveo group, as compared to the Menactra group.
In both groups, however, the clinical relevance of higher post vaccination response is unknown.
Legal Classification:
Rx
Contraindication(s):
Life-threatening reaction to any previous CRM197 or other diphtheria toxoid or meningococcal-containing vaccine.
Adults & Children:
<11yrs: not recommended. Give by IM inj only in deltoid muscle. 11–55yrs: 0.5mL once. Monitor 15min post-dose.
Precaution(s):
Immunodeficiency. Bleeding disorders (eg, hemophilia, thrombocytopenia, during anticoagulant therapy). Have epinephrine inj (1:1000) available. Possible risk of Guillain-Barre Syndrome. Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Interaction(s):
Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may get suboptimal response. Concomitant vaccines: see literature.
Adverse Reaction(s):
Inj site pain, erythema, induration; headache, malaise, nausea, myalgia, arthralgia; syncope (transient tonic-clonic movements, other seizure-like activity possible post-dose).
How Supplied:
Vials—5 doses (1 vial of lyophilized MenA conjugate component + 1 vial of liquid MenCWY conjugate component)
Last Updated:
4/1/2010
FDA批准诺华脑膜炎疫苗Menveo用于2月大婴儿
2013年8月2日，脑膜炎双球菌疫苗Menveo扩大适应症申请获得了FDA的批准。FDA批准将Menveo用于2个月以上的婴幼儿，预防4株脑膜炎奈瑟菌（血清型A，C，Y和W-135）导致的脑膜炎球菌病。
随着这一扩大适应症的获批，Menveo在美国提供了最为全面的年龄覆盖面。现在，美国的儿科医生可以为婴幼儿、儿童、青少年提供一个单一的疫苗，用于对抗4种最常见血清型脑膜炎球菌的感染。
这是首个也是唯一一个获批用于2个月大婴儿的四价脑膜炎球菌疫苗。在美国，脑膜炎球菌病发病率最高发生在婴幼儿，小于7个月大的婴儿对脑膜炎球菌病感染最为脆弱，感染几率是14-24岁年轻人的7倍。患病后，超过10%的婴儿会死亡，幸存的婴儿中，约20%会遭受终身的、毁灭性的后遗症，包括截肢、听力丧生、瘫痪和脑损伤。
FDA的批准，是基于在澳大利亚、加拿大、拉丁美洲、中国台湾、美国开展的3个随机多中心研究，涉及8700多名婴幼儿。数据表明，Menveo产生了强大的保护性免疫反应，同时在于其他常规儿科疫苗同时注射免疫时，耐受性良好。
Menveo于2010年2月获批用于青少年和成人（11-55岁），于2011年1月获批用于儿童（2-10岁）。
美国FDA公布批准Menveo(脑膜炎球菌结合疫苗)
批准日期：2010年2月19日美国FDA批准；2009年12月17日欧盟CHMP授权上市
一般描述：
MENVEO[脑膜炎球菌(组A, C, Y和W-135)寡糖白喉CRM197结合疫苗]是一种消毒液体疫苗通过肌肉注射给予，其中含脑膜炎奈瑟氏菌(N. meningitides)血清组A，C，Y和W-135 寡糖个别地结合至白喉棒状杆菌(Corynebacterium diphtheria)CRM197蛋白。通过脑膜炎奈瑟氏菌(血清组A, C, Y或W-135)的细菌发酵生产多糖。脑膜炎奈瑟氏菌株A, C, Y和W-135是各培养和生长在Franz完全培养液和用甲醛处理。通过几种提取和沉淀步骤纯化MenA, MenW-135和MenY多糖。用色谱和沉淀步骤的结合纯化MenC多糖。
通过细菌发酵并通过一系列色谱和超滤步骤纯化生产蛋白载体(CRM197)。在CY含酵母提取物和氨基酸培养液中培养和生长白喉棒状杆菌。
从纯化的多糖通过水解, 上胶(sizing)，和还原胺化为结合制备寡糖。在活化后，各寡糖被共价地连接至CRM197蛋白。纯化得到的糖结合物得到四种药物物质，组成最终疫苗。疫苗不含防腐剂或佐剂。每剂量疫苗含10 μg MenA 寡糖，5 μg各种MenC，MenY和MenW-135寡糖和32.7至64.1 μg CRM197蛋白。每剂量残留甲醛估计不超过0.30 μg。
内疫苗组分含在Type I型玻璃小瓶内，USP。容器密封材料(合成橡皮塞)不含乳胶。
适应证和用途：
MENVEO是一种疫苗适用于主动免疫接种预防脑膜炎奈瑟氏菌血清组A，C，Y和W-135引起的侵袭性脑膜炎球菌病。MENVEO被批准在11至55岁人群中使用。
剂量和给药方法：
在配制后单次给予MENVEO 0.5 mL肌肉内注射。
MENVEO由液体疫苗组分(MenCYW-135液体结合组分)和冻干疫苗组分(MenA冻干结合组分)组成。给予前立即用MenCYW-135 液体结合组分配制MenA冻干结合组。
剂型和规格：
注射用溶液(0.5-mL剂量) 以液体疫苗组分供应，通过与冻干疫苗组分配制结合，二者均在单次给予小瓶内。
禁忌证：
既往给予MENVEO，该疫苗的任何组分，或任何其它CRM197，白喉类毒素或含脑膜炎球菌疫苗有几种变态反应(如过敏反应)是给予MENVEO的禁忌证。
警告和注意事项：
给予MENVEO后发生急性变态反应，包括过敏反应必须应得到适当医学处理。
不良反应：
在临床试验中，在所有接受MENVEO的受试者中最常发生的不良事件是注射部位疼痛(41%)、头疼(30%)、肌肉痛(18%), 不适(16%)和恶心(10%)。
药物相互作用：
不要将MENVEO或其任何组分与任何其它疫苗或在相同注射器内或小瓶的稀释液混合。
在特殊人群中的使用：
尚未确定MENVEO在妊娠妇女中安全性和有效性。只有清楚需求才应给予妊娠妇女MENVEO。请纳入Novartis疫苗和Diagnostics Inc公司的妊娠注册。
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