Effectiveness of PREFLUCEL vaccination against infection with seasonalinfluenza virus in an adult and elderly population aged 50 years and older - PREFLUCEL effectiveness study in adults 50 years and older

Baxter Innovations GmbH0 个研究点目标入组 2,040 人开始时间: 2011年8月30日最近更新: 2015年4月7日

试验速览

暂无简介。

•Per indication on license, subjects who meet ALL of the following criteria are eligible for this study:
•- Subject visits a participating GP’s office;
•- Subject is 50 years of age or older at the time of GP visit;
•- Subject has an understanding of the study and provides written informed consent prior to study entry;
•- Subject presents with EU defined ILI symptoms and visits the GP’s office within 48-72 hours of onset of first symptoms;
•- Subject is willing and able to comply with the requirements of the protocol.
•PREFLUCEL-vaccinated group only:
•- Subject received PREFLUCEL vaccination of current season no more than 6 months and no less than 21 days prior to enrolment as documented in the vaccination card or medical record.
•Non-vaccianted control group:
•- Subject received NO seasonal influenza vaccination in the current season but may have received ANY seasonal influenza vaccination in the previous season (including PREFLUCEL).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1040

•Subjects who meet ANY of the following criteria are NOT eligible for this study:
•- Subject has missing or uncertain information on seasonal vaccination history for the current
•and previous season;
•- Subject received ANY seasonal influenza vaccination for the current season except
•- Subject is a family member or an employee of the investigator.

发起方