BACKGROUND:Meta-analyses enable summarization and interpretation of data across clinical trials. When applied to safety data they allow for detection of rare events. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) was approved in multiple countries worldwide for routine immunization of infants and young children. This meta-analysis was conducted to identify potentially clinically important rare safety events associated with PCV13. OBJECTIVE:To summarize the safety of PCV13 compared with 7-valent pneumococcal conjugate vaccine (PCV7) administered to infants and toddlers. METHODS:A meta-analysis was performed of integrated safety data from 13 infant studies (PCV13 n=4729 and PCV7 n=2760) conducted in 9 North American, European, and Asian countries. Local reactions at the vaccine injection site and systemic events were collected for 4-7 days after each dose into electronic diaries. Adverse events (AEs) were collected after each vaccination. RESULTS:Overall, rates of local reactions after any dose of the infant series were similar between PCV13 and PCV7 groups: tenderness (46.7% vs 44.8%, respectively); swelling (28.5% vs 26.9%); and redness (36.4% vs 33.9%). After the toddler dose, tenderness was significantly higher among PCV7 subjects than PCV13 subjects (54.4% vs 48.8%; P=0.005). Frequencies of fever (≥38°C) were similar in both groups and mostly mild (≤39°C); incidence of moderate fever (>39°C to ≤40°C) with PCV13 was ≤2.8% after any infant dose and 5.0% after the toddler dose, compared with ≤2.6% and 7.3%, respectively, with PCV7. Fever >40°C was uncommon in both groups. Frequencies of decreased appetite, irritability, and sleep disturbances were similar in both groups. AEs were the types of conditions and symptoms expected in infants and children, and clinically significant differences between vaccine groups were not observed. CONCLUSION:PCV13 has a favorable safety profile similar to that of PCV7, a vaccine for which there is >10 years clinical experience.

译文

背景:元分析可以汇总和解释整个临床试验中的数据。当应用于安全数据时,它们允许检测罕见事件。最近,一种13价肺炎球菌结合疫苗(PCV13)已在全球多个国家/地区批准用于婴儿和幼儿的常规免疫。进行了这项荟萃分析,以鉴定与PCV13相关的潜在的临床重要罕见安全事件。
目的:总结与婴幼儿使用的7价肺炎球菌结合疫苗(PCV7)相比,PCV13的安全性。
方法:对9个北美,欧洲和亚洲国家进行的13项婴儿研究(PCV13 n = 4729和PCV7 n = 2760)的综合安全性数据进行了荟萃分析。每次注射疫苗后4-7天,将疫苗注射部位的局部反应和全身性事件收集到电子日记中。每次疫苗接种后收集不良事件(AE)。
结果:总的来说,在PCV13和PCV7组中,任何剂量的婴儿系列后的局部反应率相似:压痛(分别为46.7%和44.8%);肿胀(28.5%对26.9%);和发红(36.4%比33.9%)。幼儿服药后,PCV7受试者的压痛明显高于PCV13受试者(54.4%比48.8%; P = 0.005)。两组的发烧频率(≥38°C)相似,且多数为轻度(≤39°C)。在任何婴儿剂量下,PCV13发生中度发烧(> 39°C到≤40°C)的发生率≤2.8%,在幼儿剂量后为5.0%,而PCV7分别为≤2.6%和7.3%。两组中发烧> 40°C的情况很少见。两组食欲减退,烦躁不安和睡眠障碍的频率相似。不良事件是婴儿和儿童中预期的疾病和症状类型,未观察到疫苗组之间的临床显着差异。
结论:PCV13具有与PCV7类似的良好安全性,后者具有10年以上的临床经验。

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