Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-Con

描述（研究者提供）：由于绝对建议对最脆弱人群（老年人）每年接种疫苗，出于伦理原因，只能在其中进行疫苗有效性的观察性研究。由于未被认识到的选择偏差，观察性研究的结果可能不准确。识别和调整这些偏差的研究设计策略是必要的。拟议的观察性研究包括以下策略，包括实验室确认医疗护理的流感样疾病（ILI）为流感，在监测确定的流感流行期内和之外的计划有效性估计，以及调整导致结果测量错误分类的信息缺失的新策略。我们的主要目标是评估获得许可的流感疫苗在预防实验室确认的医疗护理流感（包括流感相关并发症）方面的年度有效性。这项评估需要(1)确定因急性呼吸道疾病（ICD-9-CM 460- 466）或肺炎和流感（ICD-9-CM 480-487）的门诊医疗接触者以及因肺炎和流感（ICD-9-CM代码480-487）住院的患者队列；(2)采集患者标本，利用病毒培养和实时PCR方法对标本进行实验室处理，确认呼吸道疾病为流感；(3)确定和验证队列成员的流感疫苗接种状况；(4)实施一项机制，以便在流感季节期间获得临时有效性评估的初步数据，并在每年流感季节结束后的9月之前获得完整的数据进行总结分析和公布。我们的次要目标(5)是从300-450名65岁及以上的参与者中招募、接种疫苗并收集成对的接种前和接种后血液标本，用于评估流感疫苗接种的血清学（最多450名参与者）和细胞介导（最多150名参与者）免疫反应。所有参与者将接受一剂获得许可的灭活疫苗（时间适当，以提供季节性保护）；配对血液标本将在疫苗接种前和接种后30天的访问中收集，需要立即进行标本处理，并将标本储存在适当的储存库中，直到运往参考实验室进行检测。

DESCRIPTION (provided by investigator): Because of absolute recommendation for annual vaccination for the most vulnerable populations (the elderly), only observational studies of vaccine effectiveness can be carried out among them for ethical reasons. Results from observational studies may be inaccurate due to unrecognized selection biases. Study design strategies to identify and adjust for these biases are necessary. The proposed observational study includes such strategies including laboratory- confirmation of medically attended influenza-like illnesses (ILI) as influenza, planned effectiveness estimates within and outside of surveillance defined periods of influenza circulation and new strategies to adjust for missing information that results in misclassification of outcome measures. Our primary objective is to assess annual effectiveness of licensed influenza vaccines in preventing laboratory-confirmed medically-attended influenza, including influenza-related complications. This assessment requires (1) identification of patient cohorts that are followed for outpatient health care contacts for acute respiratory illness (ICD-9-CM 460- 466) or pneumonia and influenza (ICD-9-CM 480-487), and hospitalization for pneumonia and influenza (ICD-9-CM codes 480-487); (2) collection of specimens from ill patients and laboratory processing of specimens using viral culture and real time PCR methods to confirm respiratory illnesses as influenza; (3) determination and validation of influenza vaccination status of cohort members; and (4) implementing a mechanism such that preliminary data for interim effectiveness estimates are available during the influenza season, with complete data available for summary analyses and publication by September following annual influenza seasons. Our secondary objective (5) is to recruit, vaccinate and collect paired pre- and post-vaccination blood specimens from 300-450 participants, 65 years and older, for assessment of the serologic (up to 450 participants) and cell-mediated (up to 150 participants) immune responses to influenza vaccination. All participants will receive a single dose of a licensed inactivated vaccine (timed appropriately for seasonal protection); paired blood specimens will be collected at pre- and 30-day post-vaccination visits, required immediate specimen processing performed and specimens stored in appropriate repositories until shipped to reference labs for testing.