E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A single 0.5 mL dose administered by intramuscular injection into the deltoid muscle of Fluad is recommended for active immunisation against influenza in the elderly (65 years of age and over), especially for those with an increased risk of associated complications (i.e., patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 evaluate the safety of a single intramuscular (IM) injection of Fluad in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. |
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E.2.2 | Secondary objectives of the trial |
Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes. (Note for Guidance on Harmonization of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry. 2. Individuals able to comply with all the study requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. |
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E.4 | Principal exclusion criteria |
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject`s ability to participate in the study. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: Medically significant Cancer, prostate cancer that has been clinically stable for more than 2 years without treatment);Medically significant advanced congestive heart failure (ie. NYHA class III and IV); (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto`s thyroiditis that has been clinically stable for ≥ 5 years); Diabetes mellitus type I; Poorly controlled diabetes mellitus type II;Advanced arteriosclerotic disease;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome); Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological (es. Guillain–Barre` syndrome) or psychiatric disorder; Severe asthma. Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate; with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;suspected or known HIV infection or HIV-related disease;with known or suspected history of drug or alcohol abuse.Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject; who are not able to comprehend and to follow all required study procedures for the whole period of the study; with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due t participation in the study. Individuals Within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.Individuals that have experienced fever (i.e., axillary temperature ≥ 38�C) within the last 3 days of intended study vaccination.Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study, participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines. Individuals who ever received blood,blood products and/or plasmaimmunoglobulin,who are part ofstudy personnel;BMI > 35 kg/m2. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The following serological assessments will be considered for each strain in elderly subjects, aged 65 years and over, and at least one of the assessments should meet the indicated requirements: - Proportion of seroconversion or significant increase in HI titer or SRH area > 30% - Mean geometric increase > 2.0 - The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 60% Circulating anti-HA antibodies will be measured by SRH and possibly HI assay just prior to vaccination (Day 1) and approximately 3 weeks after the vaccination (Day 22). For the purposes of calculation, any HI result < 10 (i.e. undetectable) will be expressed as 5, and any negative SRH result will be expressed as 4 mm2. |
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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) | 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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
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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I soggetti termineranno la sperimentazione con la visita 3 dopo 3 settimane dalla visita 1. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 21 |
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 | 21 |