E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active influenza immunoprofilaxis |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021881 |
E.1.2 | Term | Infections and infestations |
|
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-immunization 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 |
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD in elderly subjects. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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:
ᄋ medical history;
ᄋ physical examination;
ᄋ clinical judgment of the investigator; |
|
E.4 | Principal exclusion criteria |
they have any serious disease such as:
ᄋ cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy;
ᄋ autoimmune disease (including rheumatoid arthritis);
ᄋ advanced arteriosclerotic disease or insulin dependent diabetes mellitus;
ᄋ chronic obstructive pulmonary disease (COPD) that requires oxygen therapy;
ᄋ acute or progressive hepatic disease;
ᄋ acute or progressive renal disease;
ᄋ congestive heart failure;
2. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin 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:
ᄋ receipt of immunosuppressive therapy (any parenteral or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
ᄋ receipt of immunostimulants;
ᄋ receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
ᄋ suspected 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's opinion would interfere with the safety of the subject;
7. within the past 12 months, they have:
ᄋ received more than one injection of influenza vaccine;
8. within the past 6 months, they have:
ᄋ had laboratory confirmed influenza disease;
ᄋ received influenza vaccine,
9. within the past 4 weeks they have received:
ᄋ another vaccine;
ᄋ any investigational agent;
10. within the past 7 days, they have experienced:
ᄋ any acute disease;
ᄋ infections 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:
ᄋ fever (i.e., body temperature >= 38ᄚC);
13. they are taking part in another clinical study;
14. they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the immunogenicity study objective, at least one of the following assessments should meet the indicated requirements for each strain:
ᄋ Elderly subject 65 years and over (i.e., ᄈ 65)
- number of seroconversions1 or significant increase in antibody titer2 > 30%
- mean geometric increase > 2.0
- the proportion of subjects achieving an SRH area >= 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 |