V. Houdouin , N. Lavis , C. Meyzer , E. Jeziorski , E. Merlin , D. Pinquier , G. Deschenes , E. Mothe , C. Petit , D. Plantaz , J. Stoller , M.-P. El Qomri , F. Dubos , P. Reix
{"title":"Safety of the Northern Hemisphere 2014/2015 formulation of the inactivated split-virion intramuscular trivalent influenza vaccine","authors":"V. Houdouin , N. Lavis , C. Meyzer , E. Jeziorski , E. Merlin , D. Pinquier , G. Deschenes , E. Mothe , C. Petit , D. Plantaz , J. Stoller , M.-P. El Qomri , F. Dubos , P. Reix","doi":"10.1016/j.vacrep.2016.07.001","DOIUrl":null,"url":null,"abstract":"<div><p>In the current study, the safety of the 2014/2015 Northern Hemisphere formulation of Vaxigrip® (Sanofi Pasteur) was assessed to satisfy European Union requirements. Individuals ⩾6<!--> <!-->months of age eligible for seasonal influenza vaccination were included. Children 6<!--> <!-->months–8<!--> <!-->years of age received one dose (0.25<!--> <!-->ml for 6–35 mo; 0.5<!--> <!-->ml for 3–8<!--> <!-->y) on day 0, and those who were previously unvaccinated received a second dose of the same volume on day 28. Participants ⩾9<!--> <!-->years of age received one full dose (0.5<!--> <!-->ml) on day 0. Frequency categories for solicited reactions were compared with historical data for the closest age group available. A total of 527 participants were included (6<!--> <!-->mo–5<!--> <!-->y, n<!--> <!-->=<!--> <!-->106; 6–12 y, n<!--> <!-->=<!--> <!-->105; 13–17 y, n<!--> <!-->=<!--> <!-->106; 18–65 y, n<!--> <!-->=<!--> <!-->105; >65 y, n<!--> <!-->=<!--> <!-->105). Frequency categories were higher in this study than for the historical comparator for fever (very common vs. common) in participants 6<!--> <!-->months–5<!--> <!-->years of age; shivering (very common vs. common), rash (uncommon vs. very rare), and grade 3 injection-site induration (common vs. uncommon) in participants 6–12<!--> <!-->years of age; and shivering in participants 13–17<!--> <!-->years of age (very common vs. common) and >65<!--> <!-->years of age (very common vs. common). However, these increases were not considered clinically significant because confidence intervals for proportions were overlapping and because most of the reactions were of grade 1 to 2 and resolved rapidly and spontaneously. No treatment-related serious adverse events were recorded and no safety concerns or safety signals were detected. These results indicate that the 2014/2015 Northern Hemisphere formulation of Vaxigrip was well tolerated and safe to use in all age groups, with no specific concerns identified, although the study was not powered to detect rare or very rare events.</p></div>","PeriodicalId":91982,"journal":{"name":"Vaccine reports","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.vacrep.2016.07.001","citationCount":"5","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S187943781630016X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 5
Abstract
In the current study, the safety of the 2014/2015 Northern Hemisphere formulation of Vaxigrip® (Sanofi Pasteur) was assessed to satisfy European Union requirements. Individuals ⩾6 months of age eligible for seasonal influenza vaccination were included. Children 6 months–8 years of age received one dose (0.25 ml for 6–35 mo; 0.5 ml for 3–8 y) on day 0, and those who were previously unvaccinated received a second dose of the same volume on day 28. Participants ⩾9 years of age received one full dose (0.5 ml) on day 0. Frequency categories for solicited reactions were compared with historical data for the closest age group available. A total of 527 participants were included (6 mo–5 y, n = 106; 6–12 y, n = 105; 13–17 y, n = 106; 18–65 y, n = 105; >65 y, n = 105). Frequency categories were higher in this study than for the historical comparator for fever (very common vs. common) in participants 6 months–5 years of age; shivering (very common vs. common), rash (uncommon vs. very rare), and grade 3 injection-site induration (common vs. uncommon) in participants 6–12 years of age; and shivering in participants 13–17 years of age (very common vs. common) and >65 years of age (very common vs. common). However, these increases were not considered clinically significant because confidence intervals for proportions were overlapping and because most of the reactions were of grade 1 to 2 and resolved rapidly and spontaneously. No treatment-related serious adverse events were recorded and no safety concerns or safety signals were detected. These results indicate that the 2014/2015 Northern Hemisphere formulation of Vaxigrip was well tolerated and safe to use in all age groups, with no specific concerns identified, although the study was not powered to detect rare or very rare events.
在目前的研究中,对Vaxigrip®(赛诺菲巴斯德)2014/2015北半球配方的安全性进行了评估,以满足欧盟要求。包括符合季节性流感疫苗接种条件的小于或等于6个月的个体。6个月至8岁的儿童接受一剂(0.25 ml, 6 - 35个月;在第0天接种0.5 ml(3-8岁),之前未接种疫苗的人在第28天接种相同体积的第二剂。小于9岁的参与者在第0天接受一次全剂量(0.5 ml)。征求反应的频率类别与可获得的最接近年龄组的历史数据进行比较。共纳入527名受试者(6 mo-5 y, n = 106;6-12 y, n = 105;13-17 y, n = 106;18-65 y, n = 105;>65 y, n = 105)。在本研究中,6个月至5岁的参与者发烧的频率类别高于历史比较物(非常常见vs常见);在6-12岁的参与者中,颤抖(非常常见vs常见),皮疹(罕见vs非常罕见)和3级注射部位硬化(常见vs不常见);13-17岁的参与者(非常常见vs.普通)和65岁的参与者(非常常见vs.普通)颤抖。然而,这些增加并不被认为具有临床意义,因为比例的置信区间重叠,而且大多数反应为1至2级,并且迅速自发地消退。没有记录到与治疗相关的严重不良事件,也没有检测到安全问题或安全信号。这些结果表明,Vaxigrip的2014/2015北半球配方在所有年龄组中都具有良好的耐受性和安全性,尽管该研究没有发现罕见或非常罕见的事件,但没有发现具体的问题。