E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination of healthy subjects aged 18 to 60 years (60 subjects) and over the 60 years (60 subjects) with one dose of the new formulation of the influenza vaccine for the 2006-2007 Northern Hemisphere season. |
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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 |
To check the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency (EMEA) Note for Guidance (NfG) CPMP/BWP/214/96. |
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E.2.2 | Secondary objectives of the trial |
To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Aged at least 18 years on the day of inclusion 2) Informed consent form signed 3) Able to attend all scheduled visits and to comply with all trial procedures 4) For a woman, inability to bear a child or negative urine pregnancy test at V01 5) For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination. |
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E.4 | Principal exclusion criteria |
1) Febrile illness (oral temperature ≥37.5°C) on the day of vaccination 2) Breast-feeding 3) Participation in another clinical trial in the four weeks preceding the trial vaccination 4) Planned participation in another clinical trial during the present trial period 5) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy 6) Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances 7) Chronic illness at a stage that could interfere with trial conduct or completion 8) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures 9) Blood or blood-derived products received in the past three months 10) Any vaccination in the four weeks preceding the trial vaccination 11) Vaccination planned in the three weeks following the trial vaccination 12) Previous vaccination against influenza in the previous 6 months 13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination 14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
For each vaccine strain:
- Individual anti-Hemagglutinin (HA) antibody titers ratio D21/D0,· - Seroprotection status: titer ≥40 (1/dil) on D0 and D21, - Seroconversion for subjects with a titer <10 (1/dil) on D0: post-injection titer ≥40 (1/dil) on D21 or significant increase for subjects with a titer ≥10 (1/dil) on D0: ≥4-fold increase of post-injection titer on D21. |
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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 | Yes |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |