E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against Influenza in healthy male and female subjects aged over 18 years |
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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 |
1. Descriptive analysis of the humoral immune response after intramuscular administration of a trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine on day 21 (± 2) after vaccination. 2. Descriptive analysis of the reactogenicity after intramuscular administration of the trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years), measured on the solicited local symptoms PAIN, REDNESS, INDURATION and solicited general symptoms FEVER, SHIVERING, FATIGUE, HEADACHE, SWEATING, MYALGIA and ARTHRALGIA according to the criteria of the CPMP, overall incidence and occurrence of symptoms (separate analysis for symptoms graded 13 and 23 respectively).
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E.2.2 | Secondary objectives of the trial |
1. Descriptive analysis of the humoral immune response after intramuscular administration of the trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by seroconversion rate or significant increase of the haemagglutination-inhibition antibodies and seroprotection rate against the three influenza virus strains represented in the vaccine on day 21 (± 2) after vaccination and to consider if the parameter is in correlation to the criteria of CPMP. 2. Serious adverse events for the vaccine occurring the study period will be recorded.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. A male or female aged 18 years of age at the time of the vaccination, not vaccinated against influenza in the previous season. 2. Written informed consent obtained from the subject.
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E.4 | Principal exclusion criteria |
3. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. 4. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/axillary temperature < 37.5°C. 5. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. 6. Pregnant female. 7. Female who is willing to become pregnant during the period starting the day of vaccination and ending one month after vaccination. 8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Descriptive analysis of the humoral immune response after intramuscular administration of the new trivalent influenza split vaccine 2004/2005 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine on day 21 (± 2) after vaccination. 2. Descriptive analysis of the reactogenicity after intramuscular administration of the new trivalent influenza split vaccine 2004/2005 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years), measured on the solicited local symptoms PAIN, REDNESS, INDURATION and solicited general symptoms FEVER, SHIVERING, FATIGUE, HEADACHE, SWEATING, MYALGIA and ARTHRALGIA according to the criteria of the CPMP, overall incidence and occurrence of symptoms (separate analysis for symptoms graded 13 and 23 respectively)
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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.8.5 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |