E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active influenza immunoprofilaxis |
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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 |
|
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 antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in elderly subjects in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). |
|
E.2.2 | Secondary objectives of the trial |
Valutare la sicurezza della somministrazione di una singola iniezione intramuscolare (IM) di FLUAD in soggetti anziani. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
2.able to comply with all the study requirements;
3.in general good health as determined by: (i)medical history; (ii)physical examination; (iii)clinical judgment of the investigator; |
|
E.4 | Principal exclusion criteria |
1.any serious disease such as:
ᄋcancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy;
ᄋautoimmune disease (including rheumatoid arthritis);
ᄋadvanced arteriosclerotic disease or insulin dependent diabetes mellitus;
ᄋchronic obstructive pulmonary disease (COPD) that requires oxygen therapy;
ᄋacute or progressive hepatic disease;
ᄋacute or progressive renal disease;
ᄋcongestive heart failure;
2.hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
4. they have a 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:
ᄋreceipt of immunosuppressive therapy (any parenteral or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and/or for the full length of the study;
ᄋreceipt of immunostimulants;
ᄋreceipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
ᄋsuspected or known HIV infection or HIV-related disease;
5. they have a known or suspected history of drug or alcohol abuse;
6. they have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigatorメs opinion would interfere with the safety of the subject;
7. within the past 12 months, they have:
ᄋreceived more than one injection of influenza vaccine;
8. within the past 6 months, they have:
ᄋhad laboratory confirmed influenza disease;
ᄋreceived influenza vaccine,
9. within the past 4 weeks they have received:
ᄋanother vaccine;
ᄋany investigational agent;
10. within the past 7 days, they have experienced:
ᄋany acute disease;
ᄋinfections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
11. they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days;
12. within the past 3 days, they have experienced:
ᄋfever (i.e., axillary temperature >= 38ᄚC);
13.they are taking part in another clinical study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
For each strain at least one of the following assessments should meet the indicated requirements :
- number of seroconversions1 or significant increase in antibody titer2 > 30%
- mean geometric increase > 2.0
- the proportion of subjects achieving an SRH area ᄈ 25 mm2 should be > 60% |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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
| 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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |