E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients withAge >= 60 years |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016790 |
E.1.2 | Term | Flu |
|
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 |
On field assessment of the safety and the tolerability of a new influenza vaccine, Intanza Sanofi Pasteur, in a cohort of subjects >= 60 years. Assessment of the immunogenicity and ability of intradermal influenza vaccine to elicit an effective antibody response against circulating viruses presenting different antigenic pattern respect to that of vaccine strains. Assessment of the acceptability of the new vaccine Intanza by the users. Assessment of the compliance with vaccination with the new preparation Intanza by the physicians. |
|
E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age >= 60 years [at the date of study enrollment] 2. Written informed consent 3. Capability to present to all scheduled visits and follow all the procedures of the study |
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E.4 | Principal exclusion criteria |
1. Known anaphylactic hypersensitivity reactions to egg proteins (eggs or egg products), chicken proteins, or any other component of the vaccine including traces (formaldehyde, octoxinol 9 (Triton X-100) and neomycin). 2. Acute febrile illness (axillary temperature  37.5C) at enrollment time. 3. Partecipation in another clinical trial within the previous 4 weeks. 4. Planned participation in another clinical trial in the same period of this study. 5. Current alcohol abuse or addiction to drugs that might interfere with the capability of the subject to follow the procedures of the study. 6. Previous influenza vaccination (within 6 months) with the same formulations upon study or other formulations. 7. Subject deprived of his liberty by administrative order or tribunal, or requiring emergency aid or hospitalized without his consent. 8. Any clinical condition which, in the opinion of the investigator, might interfere with conduction or completion of the study. 9. Subject with any condition which, in the opinion of the investigator, might interfere with the assessment of the objectives of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
On field assessment of the safety and the tolerability of a new influenza vaccine, Intanza Sanofi Pasteur, in a cohort of subjects ≥ 60 years. Assessment of the immunogenicity and ability of intradermal influenza vaccine to elicit an effective antibody response against circulating viruses presenting different antigenic pattern respect to that of vaccine strains. Assessment of the acceptability of the new vaccine Intanza by the users. Assessment of the compliance with vaccination with the new preparation Intanza by the physicians. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Accettabilita` dei pazienti e compliance dei medici alla sua somministrazione |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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.8.4.1 | 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
| |
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 | |
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 |