E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against Influenza in healthy children and children with underlying diseases aged between 6 and 13 years |
|
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 |
Descriptive analysis of the humoral immune response after one or two dose intramuscular administration of a trivalent influenza split vaccine 2005/2006 in children from 6 years to 9 years measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine and measured by the seroconversion rate |
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E.2.2 | Secondary objectives of the trial |
1.Descriptive analysis of the humoral immune response after one dose intramuscular administration of a trivalent influenza split vaccine 2005/2006 in children from 10 years to 13 years measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine and measured by the seroconversion rate
2. Descriptive analysis of report, kind and intensity of local and systemic symptoms and serious adverse events occuring over the study period. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Healthy children or children with underlying disease aged from 6 to 13 years 2. Only children, which were never vaccinated before or have never experienced a confirmed influenza before, can be enrolled 3. Written informed consent obtained by the parents |
|
E.4 | Principal exclusion criteria |
4. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the vaccination, or planned use during the study period 5. Acute disease at the time of enrolment 6. History of allergic disease or reactions |
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E.5 End points |
E.5.1 | Primary end point(s) |
Descriptive analysis of the humoral immune response after the first dose (Group 1) or the only one dose (Group 2) of the trivalent influenza split vaccine 2005/2006 measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies and the criteria seroconversion rate, seroconversion factor and protection rate according to the CPMP criteria for adults |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
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 | Information not present in EudraCT |
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
| |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |