Safety and Tolerability of a 13-Valent Pneumococcal Conjugated Vaccine Distributed in the Public Immunization Program of the Municipality of Campos dos Goytacazes, Rio de Janeiro, Brazil

C. Kury, A. Wilken, R. Henriques, Renata de Carvalho Salles, Wilza Abreu de Brito, M. Kury, Rafael Pessanha de Sá, Felipe Pessanha de Sá
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Abstract

From september to december, 2010, we have assessed the frequency and occurrence of adverse events to Pneumo-coccal conjugated 13-valent vaccine (PCV-13) in the Public vaccination program of the municipality of Campos dos Goytacazes, State of Rio de Janeiro, the unique city in Brazil that has introduced this vaccine in it’s immunization schedule. This study analyzed 1001 toddlers who have received PCV-13 at 3, 5 and 7 months and a booster dose at 12 months. We observed a total of 514 local and systemic events in 303 subjects (30.2% of 1001 infants). The most reported systemic events were irritability (18.8%) and fever or = 38.5°C (8.8%), loss of appetite (8.4%). Erythema (11.2%) and local pain (9.4%) were the most reported local events. Other events reported were diarrhea (6.2%), increased sleep (5.1%), edema and induration (4.8%), decreased sleep (4.3%), vomiting (1.4%), eruption (1.2%) urticaria (0.8%), prurience (0.8%), lymphadenopathy (0.2%) and hypersensitivity reaction (0.2%). There wasn’t any reported case of convulsion or Hospital admission. When stratified by each dose, irritability (systemic) and erythema (local) were the most common events reported at the first and fourth dose, although fever < 38.5°C (systemic) and pain (local) were the most common at second and third doses. Results were close to those encountered in product monograph. In our study, PCV-13 was secure in pneumococcal disease prevention and well tolerated.
巴西里约热内卢Campos dos Goytacazes市公共免疫规划中分配的13价肺炎球菌结合疫苗的安全性和耐受性
2010年9月至12月,我们评估了里约热内卢州坎波斯多斯戈伊塔卡泽斯市公共疫苗接种计划中肺炎球菌结合13价疫苗(PCV-13)不良事件的频率和发生情况,这是巴西唯一一个将该疫苗纳入其免疫计划的城市。这项研究分析了1001名在3个月、5个月和7个月时接受过PCV-13疫苗接种的幼儿,并在12个月时接受了加强剂量的疫苗接种。我们在303名受试者(1001名婴儿的30.2%)中观察到总共514例局部和全身事件。报告最多的系统事件是烦躁(18.8%)和发热(38.5°C)(8.8%),食欲不振(8.4%)。红斑(11.2%)和局部疼痛(9.4%)是报告最多的局部事件。其他报告的事件有腹泻(6.2%)、睡眠增加(5.1%)、水肿和硬结(4.8%)、睡眠减少(4.3%)、呕吐(1.4%)、皮疹(1.2%)、荨麻疹(0.8%)、搔痒(0.8%)、淋巴结病(0.2%)和超敏反应(0.2%)。没有任何惊厥或住院的报告。当按每个剂量分层时,在第一次和第四次剂量时报告的最常见事件是烦躁(全身)和红斑(局部),尽管在第二次和第三次剂量时最常见的是发烧< 38.5°C(全身)和疼痛(局部)。所得结果与产品专论接近。在我们的研究中,PCV-13在预防肺炎球菌疾病方面是安全的,并且耐受性良好。
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