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Adverse events following immunization with typhoid conjugate vaccine in an outbreak setting in Hyderabad, Pakistan.
Vaccine ( IF 5.5 ) Pub Date : 2020-03-20 , DOI: 10.1016/j.vaccine.2020.03.028
Farah Naz Qamar 1 , Mohammad Tahir Yousafzai 2 , Asif Khaliq 1 , Sultan Karim 1 , Hina Memon 1 , Amber Junejo 1 , Inayat Baig 1 , Najeeb Rahman 1 , Shafqat Bhurgry 3 , Hina Afroz 4 , Uzma Sami 4
Affiliation  

Pakistan is facing the world's largest outbreak of extensively drug-resistant (XDR) Typhoid. Vaccination campaign for children aged 6 months to 10 years old with Typhoid Conjugate Vaccine (Typbar-TCV®) was conducted in high-risk areas of Hyderabad during 2018. About 207,000 children were vaccinated. Here we report the adverse events following immunization (AEFI) during the campaign. The campaign was carried out using outreach and fixed centre strategy. Community mobilizers visited each household to perform line listing and mobilize parents with age-eligible children. Children were observed for 30 min post-vaccination. Two-pronged strategy was used for ascertainment of AEFI. A 24/7 hotline number was provided to all parents/caretakers (n = 199,861) to report AEFI during 14 days following immunization. An age-stratified (n = 7139 children) were actively followed at days 7 and 14 for the ascertainment of AEFI. All AEFI were examined by three trained medical officers. A structured questionnaire using Brighton collaboration criteria with level 3 diagnostic certainty was used for the recording of AEFI. Data were analysed using Microsoft Excel Office 365. Overall, 499 AEFI (433 in the subset actively followed and 66 self-reported through hotline) were observed. The rate of AEFI was significantly higher among very young children (age group 6 to 12 months) as compared to 2 to 3 years old children (0.54% vs. 0.33% respectively; p-value < 0.001). Fever was the most common AEFI self-reported through the hotline (38/199,861 = 0.02%) and among the subset followed actively for 14 days (206/7139 = 2.89%). Fever was followed by local reactogenicity 10/199,861(0.01%), and 134/7139 (1.88%) through self-reported hotline and active follow-up, respectively. No serious AEFI was observed. Administration of a single dose of Typbar-TCV among children aged 6 months to 10 years old during an outbreak setting of Hyderabad Pakistan was safe.

中文翻译:

在巴基斯坦海得拉巴的疫情暴发中,使用伤寒缀合物疫苗免疫后的不良事件。

巴基斯坦正面临着全球最大的广泛耐药(XDR)伤寒暴发。2018年期间,在海得拉巴高风险地区开展了针对6个月至10岁的伤寒共轭疫苗(Typbar-TCV®)的儿童疫苗接种运动。约有207,000名儿童接种了疫苗。在这里,我们报告了运动期间免疫接种后的不良事件(AEFI)。该运动是使用外展和固定中心战略进行的。社区动员者走访了每个家庭,进行行列表并动员有年龄的孩子的父母。接种后30分钟观察儿童。采用两管齐下的策略确定AEFI。为所有父母/看护者提供了24/7热线电话(n = 199,861),以在免疫后14天内报告AEFI。在第7天和第14天积极追踪年龄分层(n = 7139名儿童)以确定AEFI。所有的AEFI均由三名训练有素的医务人员进行检查。使用具有3级诊断确定性的布莱顿协作标准的结构化问卷,用于记录AEFI。使用Microsoft Excel Office 365分析数据。总体上,观察到499 AEFI(积极跟踪该子集中的433,通过热线自我报告的66)。与2至3岁的儿童相比,极年轻的儿童(6至12个月的年龄组)的AEFI比率显着更高(分别为0.54%和0.33%; p值<0.001)。发烧是通过热线自我报告的最常见的AEFI(38 / 199,861 = 0.02%),在子集中积极随访了14天(206/7139 = 2.89%)。发烧后出现局部反应原性10/199,自我报告的热线电话和主动随访的电话分别为861(0.01%)和134/7139(1.88%)。没有观察到严重的AEFI。在巴基斯坦海得拉巴暴发期间,对6个月至10岁的儿童服用单剂Typbar-TCV是安全的。
更新日期:2020-03-20
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