A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial

Block Stan L.; Szenborn Leszek; Daly Wendy; Jackowska Teresa; DAgostino Diego; Han Linda; Dull Peter M.; Smolenov Igor

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A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial

机译：两种研究性脑膜炎球菌ABCWY疫苗制剂的比较评估：2期随机对照试验的结果

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Background: A meningococcal vaccine protective against all major disease-associated serogroups (A, B, C, W and Y) is an unmet public health need. In this phase 2 observer-blinded, randomized, controlled study, two investigational meningococcal ABCWY vaccine formulations were evaluated to assess their immunological noninferiority to a licensed quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM) for serogroups ACWY and immunogenicity against serogroup B test strains, as well as for formulation selection based on a desirability index (DI). Each investigational MenABCWY formulation contained recombinant protein and outer membrane vesicle (OMV) components of a licensed serogroup B vaccine (4CMenB) combined with components of MenACWY-CRM.

机译：背景：针对所有主要疾病相关血清群（A，B，C，W和Y）的保护性脑膜炎球菌疫苗是未满足的公共卫生需求。在该2期观察者盲目的随机对照研究中，评估了两种研究性脑膜炎球菌ABCWY疫苗制剂，以评估其对于许可的血清型ACWY的四价脑膜炎球菌ACWY糖缀合物疫苗（MenACWY-CRM）的免疫学非劣性，以及针对血清B组测试株的免疫原性，以及基于期望指数（DI）的配方选择。每个研究性MenABCWY制剂均包含重组的蛋白质和许可的B血清群疫苗（4CMenB）的外膜囊泡（OMV）组分，并结合MenACWY-CRM的组分。

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《Vaccine》 |2015年第21期|共11页
作者
Block Stan L.; Szenborn Leszek; Daly Wendy; Jackowska Teresa; DAgostino Diego; Han Linda; Dull Peter M.; Smolenov Igor;
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正文语种 eng
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Conjugate vaccines; Meningococcal; Immunogenicity; Safety; Adolescent;

机译：结合疫苗;门球菌;免疫原性;安全性;青少年;

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1. A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial [J] . Block Stan L., Szenborn Leszek, Daly Wendy, Vaccine . 2015,第21期

机译：两种研究性脑膜炎球菌ABCWY疫苗制剂的比较评估：2期随机对照试验的结果
2. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. [J] . Findlow J, Borrow R, Snape MD, Clinical infectious diseases . 2010,第10期

机译：多中心，开放标签，II期随机对照试验研究性重组B型脑膜炎球菌血清群疫苗，有或没有外膜囊泡，均在婴儿期施用。
3. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. [J] . Findlow J, Borrow R, Snape MD, Clinical infectious diseases . 2010,第10期

机译：多中心，开放标签，II期随机对照试验研究性重组B型脑膜炎球菌血清群疫苗，有或没有外膜囊泡，均在婴儿期施用。
4. A randomized controlled clinical trial to evaluate the effect of an intranasal respiratory vaccine on calf health, ultrasonographic lung consolidation, and growth in Holstein dairy calves [C] . T. L. Ollivett, K. E. Leslie, T. Duffield, Annual Conference of the American^Association^of^Bovine^Practitioners., Conference . 2014

机译：一种随机对照临床试验，评价鼻内呼吸疫苗对荷斯坦乳制牛犊牛犊健康，超声肺固结和生长的影响
5. Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial. [D] . Fadol, Yasmin. 2016

机译：超声疗法对双侧咬肌肌痛的即时效果：随机单盲试验。
6. 1083Comparative Evaluation of Two Different Investigational Meningococcal ABCWY Vaccine Formulations in Adolescents and Young Adults [O] . Stan L. Block, Leszek Szenborn, Wendy Daly, 2014

机译：1083在青少年和年轻人中两种不同的研究性脑膜炎球菌ABCWY疫苗制剂的比较评价
7. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. [O] . Findlow, J, Borrow, R, Snape, MD, 2010

机译：多中心，开放标签，II期随机对照试验研究性重组B型脑膜炎球菌血清群疫苗，有或没有外膜囊泡，均在婴儿期施用。

A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial

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