E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
influenza A (H1N1) virus infection |
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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 |
Evaluate new influenza A (H1N1) disease (pandemic influenza) incidence of vaccinated compared to unvaccinated individuals. |
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E.2.2 | Secondary objectives of the trial |
Secondary: • Obtain data on immunogenicity of pandemic influenza vaccination: - Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus. - Evaluation of the cellular response to the vaccines and correlate this to protection against the virus. - Evaluation of the response to the second dose of the pandemic influenza vaccine.
•Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples. •Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects have to fulfill all of the following criteria: - age 18 – 52 years - good self-reported health according to the investigator - willingness and ability to adhere to the study regimen - having a signed informed consent (IC) form
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E.4 | Principal exclusion criteria |
The contra-indications for receiving the pandemic influenza vaccine are exclusion criteria: allergy to any of the components of the vaccine or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB). The exclusion criteria for blood collection and the immunological analysis are: - immune deficiencies - haematological disorders - bleeding disorders - usage of anticoagulants, corticosteroids, NSAIDs and/or statins - diabetes mellitus - having had an infectious disease with fever within the last two weeks - previously diagnosed with pandemic H1N1 influenza
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E.5 End points |
E.5.1 | Primary end point(s) |
pandemic influenza virus identification after reporting of influenza-like symptoms by the participants. |
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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 | No |
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 | No |
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 |
incidence of pandemic influenza in correlation with vaccination and immunogenicity |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 2 |
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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The last visit of the last subject, which is the last blood draw at the end of the pandemic wave in the Netherlands. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |