E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization of children against infection caused by pandemic influenza (H1N1)09 virus. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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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 assess tolerability/safety (incidence of adverse events) of the study drug after Day 10. following the vaccination. |
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E.2.2 | Secondary objectives of the trial |
To assess the long-term safety of the study drug 50-60 days after immunization. To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children aged 6 to 36 months, both sexes; Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition with adequately treated systemic diseasis (e.g. asthma or diabetes), not enlisted as exclusion criteria, upon judgement of the investigator; The legitimate representative of the volunteer is able to understand and comply with planned study procedures; The legitimate representative of the volunteer provides written informed consent prior to initiation of study procedures; Absence of existence of any exclusion criteria.
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E.4 | Principal exclusion criteria |
Known allergy to eggs or other components of the vaccine (in particular mercury); History of Guillain-Barré syndrome; Active neoplasm; Former or on-going immunosuppressive therapy; Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids; Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; Documented HIV, HBV or HCV infection; Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study; Acute febrile respiratory illness within one week prior to vaccination; Vaccine therapy within 4 weeks prior to vaccination; Influenza vaccination within 6 months prior to vaccination; Experimental drug therapy within 1 month prior to vaccination; Existing or former psychiatric illness of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative; Alcohol or drug abuse of the legitimate representative.
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment tolerability/safety (incidence of adverse events) of the study drug after Day 10. following the vaccination. Assessment of the long-term safety of the study drug 50-60 days after immunization. Assessment of the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
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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 | 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) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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Visit between 50. and 60. day after vaccination. |
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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 | 2 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |