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.
Conditions
Interventions
Trade Name: PREFLUCEL - Injektionssuspension in einer Fertigspritze
Product Name: PREFLUCEL - Injektionssupension in einer Fertigspritze
Pharmaceutical Form: Suspension for injection
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome measure is the number of subjects developing influenza infection, as confirmed by viral culture and typing of throat, nasal and/or nasopharyngeal specimens, with an influenza virus that is antigenically similar to the one of the three strains contained in the vaccine;Secondary Objective: The secondary outcome measure is the number of subjects developing influenza infection, as confirmed by viral culture and typing of throat, nasal and/or nasopharyngeal specimens, disregarding antigenic similarity.;Primary end point(s): The number of subjects developing influenza infection, as confirmed by viral culture and typing of throat, nasal and/or nasopharyngeal specimens, with an influenza virus that is antigenically similar to the one of the three strains contained in the vaccine (antigenic similarity is defined in Section 10.2.3 of the protocol).;Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number of subjects developing influenza infection, as confirmed by viral culture and typing of throat, nasal and/or nasopharyngeal specimens, disregarding antigenic similarity.;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
Austria
Contacts
Public ContactRichard Steinbrugger
Baxter Innovations GmbH
Outcome results
None listed