Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada.
Centre Hospitalier Universitaire de Québec, Québec, Québec, Canada.
Vaccine. 2018 Apr 12;36(16):2166-2175. doi: 10.1016/j.vaccine.2018.02.093. Epub 2018 Mar 13.
Ongoing assessment of influenza vaccine effectiveness (VE) is critical to inform public health policy. This study aimed to determine the VE of trivalent influenza vaccine (TIV) for preventing influenza-related hospitalizations and other serious outcomes over three consecutive influenza seasons.
The Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) conducted active surveillance for influenza in adults ≥16 years (y) of age during the 2011/2012, 2012/2013 and 2013/2014 seasons in hospitals across Canada. A test-negative design was employed: cases were polymerase chain reaction (PCR)-positive for influenza; controls were PCR-negative for influenza and were matched to cases by date, admission site, and age (≥65 y or <65 y). All cases and controls had demographic and clinical characteristics (including influenza immunization status) obtained from the medical record. VE was estimated as 1-OR (odds ratio) in vaccinated vs. unvaccinated patients × 100%. The primary outcome was VE of TIV for preventing laboratory-confirmed influenza-related hospitalization; secondary outcomes included VE of TIV for preventing influenza-related intensive care unit (ICU) admission/mechanical ventilation, and influenza-related death.
Overall, 3394 cases and 4560 controls were enrolled; 2078 (61.2%) cases and 2939 (64.5%) controls were ≥65 y. Overall matched, adjusted VE was 41.7% (95% Confidence Interval (CI): 34.4-48.3%); corresponding VE in adults ≥65 y was 39.3% (95% CI: 29.4-47.8%) and 48.0% (95% CI: 37.5-56.7%) in adults <65 y, respectively. VE for preventing influenza-related ICU admission/mechanical ventilation in all ages was 54.1% (95% CI: 39.8-65.0%); in adults ≥65 y, VE for preventing influenza-related death was 74.5% (95% CI: 44.0-88.4%).
While effectiveness of TIV to prevent serious outcomes varies year to year, we demonstrate a statistically significant and clinically important TIV VE for preventing hospitalization and other serious outcomes over three seasons. Public health messaging should highlight the overall benefit of influenza vaccines over time while acknowledging year to year variability. ClinicalTrials.gov Identifier: NCT01517191.
持续评估流感疫苗的有效性(VE)对于制定公共卫生政策至关重要。本研究旨在确定三价流感疫苗(TIV)在连续三个流感季节预防流感相关住院和其他严重后果的 VE。
加拿大免疫研究网络(CIRN)的严重后果监测(SOS)网络在加拿大各地的医院对 16 岁及以上成年人进行了 2011/2012、2012/2013 和 2013/2014 三个流感季节的主动监测。采用病例对照研究设计:病例为聚合酶链反应(PCR)检测到的流感阳性;对照组为 PCR 检测到的流感阴性,并与病例按日期、入院地点和年龄(≥65 岁或<65 岁)进行匹配。所有病例和对照组均从病历中获得人口统计学和临床特征(包括流感免疫状况)。VE 估计为接种疫苗与未接种疫苗患者的比值比(OR)1-×100%。主要结局是 TIV 预防实验室确诊的流感相关住院的 VE;次要结局包括 TIV 预防流感相关重症监护病房(ICU)入院/机械通气和流感相关死亡的 VE。
共纳入 3394 例病例和 4560 例对照;2078 例(61.2%)病例和 2939 例(64.5%)对照≥65 岁。总体上,调整后的匹配 VE 为 41.7%(95%置信区间(CI):34.4-48.3%);≥65 岁成年人的相应 VE 为 39.3%(95% CI:29.4-47.8%)和<65 岁成年人的 48.0%(95% CI:37.5-56.7%)。所有年龄段预防流感相关 ICU 入院/机械通气的 VE 为 54.1%(95% CI:39.8-65.0%);≥65 岁成年人预防流感相关死亡的 VE 为 74.5%(95% CI:44.0-88.4%)。
尽管 TIV 预防严重后果的有效性每年都有所不同,但我们在三个季节中证明了 TIV 预防住院和其他严重后果具有统计学意义和临床重要性。公共卫生信息应强调流感疫苗随着时间的推移带来的整体益处,同时承认每年的变化。临床试验注册编号:NCT01517191。