Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.
Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.
Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.
Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children 2-10 years of age, and in 2011 for infants/toddlers 9-23 months of age. We conducted two studies at Kaiser Permanente Northern California (KPNC), an integrated health care organization, to assess the safety of MenACWY-D in 2-10-year-olds and 9-23-month-olds receiving the vaccine during routine clinical care.
We conducted observational, retrospective studies of MenACWY-D in 2-10-year-olds (October 2007-October 2010) and in 9-23-month-olds (June 2011-June 2014). We monitored all subjects for non-elective hospitalizations, emergency department visits, and selected outpatient outcomes (specified neurological conditions, hypersensitivity reactions and new-onset autoimmune diseases) up to 6 months after vaccination, depending on the study. Using a self-control risk-interval design, we calculated incidence rate ratios (IRRs) comparing outcomes during the post-vaccination risk interval (0-30 days) with those during more remote post-vaccination comparison intervals (31-60 and 31-180 days [children] or 31-75 days [infants/toddlers]).
There were 1421 children aged 2-10 years and 116 infants/toddlers aged 9-23 months who received MenACWY-D. Approximately 30% of the 2-10-year-olds and 67% of the 9-23-month-olds were considered at increased risk of meningococcal disease. Among 2-10-year-olds, there was 1 hospitalization on post-vaccination day 5 for fever, which was considered possibly related to vaccination. The only significantly elevated outcome among 2-10-year-olds was cellulitis/abscess (2 cases occurred during the risk interval versus 0 during comparison interval; IRR not evaluable [NE], 95% CI: 1.42, NE). After medical record review, the 2 cases were considered unrelated to vaccination. Among 9-23-month-olds, no outcomes were significantly elevated after vaccination and there were no hospitalizations. There were no deaths observed during the three-year accrual and subsequent six-month surveillance period for either study.
Immunization of infants and young children with MenACWY-D vaccine was not associated with any new safety concerns; however, these small studies had limited power to detect rare or uncommon safety events. ClinicalTrials.gov Identifiers are NCT00728260 and NCT01689155.
Menactra®疫苗（MenACWY-D）于 2005 年在美国获得许可，适用于 11-55 岁人群，2007 年适用于 2-10 岁儿童，2011 年适用于 9-23 个月龄婴儿/幼儿。我们在 Kaiser Permanente Northern California（KPNC）进行了两项研究，这是一家综合性医疗机构，旨在评估 MenACWY-D 在接受常规临床护理的 2-10 岁儿童和 9-23 个月龄婴儿/幼儿中的安全性。
我们对 2-10 岁儿童（2007 年 10 月至 2010 年 10 月）和 9-23 个月龄婴儿/幼儿（2011 年 6 月至 2014 年 6 月）的 MenACWY-D 进行了观察性、回顾性研究。我们监测了所有受试者的非选择性住院、急诊就诊和选定的门诊结果（特定神经疾病、过敏反应和新发生的自身免疫性疾病），具体取决于研究，最长可达接种疫苗后 6 个月。使用自我对照风险间隔设计，我们计算了接种疫苗后风险间隔（0-30 天）与接种疫苗后更遥远的比较间隔（31-60 天和 31-180 天[儿童]或 31-75 天[婴儿/幼儿]）期间的结果发生率比（IRR）。
共有 1421 名 2-10 岁儿童和 116 名 9-23 个月龄婴儿/幼儿接受了 MenACWY-D。大约 30%的 2-10 岁儿童和 67%的 9-23 个月龄婴儿/幼儿被认为有患脑膜炎球菌病的高风险。在 2-10 岁儿童中，有 1 例发热的接种后第 5 天住院，这被认为可能与疫苗接种有关。在 2-10 岁儿童中唯一显著升高的结果是蜂窝织炎/脓肿（2 例发生在风险间隔期，而 0 例发生在比较间隔期；不可评估的发病率比[NE]，95%置信区间：1.42，NE）。经过病历审查，这 2 例与疫苗接种无关。在 9-23 个月龄婴儿/幼儿中，接种疫苗后没有任何结果显著升高，也没有住院治疗。在两项研究的三年累积和随后的六个月监测期间，均未观察到死亡。
婴儿和幼儿接种 MenACWY-D 疫苗不会引起任何新的安全性问题；然而，这些小型研究的能力有限，无法检测罕见或不常见的安全性事件。ClinicalTrials.gov 标识符为 NCT00728260 和 NCT01689155。
