PREFLUCEL effectiveness study in adults 50 years and older

• Conditions: To verify the effectiveness of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2011/2012 and 2012/2013 season respectively, manufactured using an adjusted splitting process.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003106-24-AT
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-30
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

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

Exclusion Criteria

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
PREFLUCEL;
- Subject is a family member or an employee of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified