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首页> 外文期刊>Expert opinion on biological therapy >Review of a new fully liquid, hexavalent vaccine: Hexaxim.
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Review of a new fully liquid, hexavalent vaccine: Hexaxim.

机译：审查一种新的完全液态的六价疫苗：六六六。

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The introduction of injectable vaccines targeting new diseases into childhood immunization programs has resulted in the need for combination vaccines to reduce the number of injections given during early childhood and maintain acceptability of targeting multiple pathogens by vaccination. Currently, there is only one licensed hexavalent combination vaccine which targets diphtheria, polio, tetanus, Haemophilus influenzae type b, hepatitis B and pertussis. A new, fully liquid formulation hexavalent vaccine ( Hexaxim ) has been developed and is currently undergoing licensure for use in childhood immunization programs. AREAS COVERED: Safety and immunogenicity studies of Hexaxim have been undertaken in a diversity of settings, been evaluated with different dosing schedules and in comparison to the other licensed hexavalent vaccine (Infanrix hexa). This review of published journal articles and conference proceeding is focused on the studies in which Hexaxim has been evaluated and which are contributing to its pending licensure. Non-inferiority was demonstrated at the level of proportion of children developing seroprotective titers or showing seroconversion following the primary series of vaccine compared to the same target-antigens included in licensed combination vaccines. Also, Hexaxim was associated with a favorable safety and tolerability profile when administered during the first 6 months of life. Adequate and robust memory responses were elicited following a booster dose in the second year of life. EXPERT OPINION: The development of new hexavalent combination vaccines targeting established pathogens is likely to assist in improving compliance and timeliness of vaccination in infants. These formulations will, however, need to be monitored for medium- and long-term effectiveness amidst growing concern of waning immunity against diseases such as pertussis when using acellular-pertussis vaccine and possibly hepatitis B when using combination vaccines. Nevertheless, the development of such combination vaccines remains necessary to help with the introduction of other new vaccines into an already crowded childhood immunization schedules.
机译：将针对新疾病的可注射疫苗引入儿童免疫计划已导致对组合疫苗的需求，以减少儿童早期注射的次数并保持通过疫苗靶向多种病原体的可接受性。当前，仅存在一种针对白喉，脊髓灰质炎，破伤风，b型流感嗜血杆菌，乙型肝炎和百日咳的许可六价组合疫苗。已经开发出一种新的，全液体制剂的六价疫苗（Hexaxim），目前正在获得许可，可用于儿童免疫计划。覆盖的区域：己克西辛的安全性和免疫原性研究已在多种环境中进行，已通过不同的给药方案进行了评估，并与其他许可的六价疫苗（六价）进行了比较。本文对已发表的期刊文章和会议记录的审查重点在于已对Hexaxim进行评估的研究，这些研究正在为其未决的许可做出贡献。与许可的联合疫苗中包含的相同靶抗原相比，在主要系列疫苗接种后儿童出现血清保护性滴度或显示血清转化的儿童比例方面，证明了非劣效性。同样，在生命的头6个月内服用Hexaxim也具有良好的安全性和耐受性。在生命的第二年增加剂量后，会引起足够而有力的记忆反应。专家意见：针对既定病原体的新型六价组合疫苗的开发可能有助于改善婴儿的依从性和及时性。然而，由于人们越来越担心使用无细胞百日咳疫苗时对百日咳等疾病的免疫力下降，以及使用联合疫苗时可能对乙型肝炎的免疫力越来越弱，因此需要对这些制剂的中长期效果进行监测。然而，仍然有必要开发这种组合疫苗，以帮助将其他新疫苗引入已经拥挤的儿童免疫计划中。

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