E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Effectiveness of Influenza Prophylaxis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |