E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at 21 days post-immunization in non-elderly adult and 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). |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety of the administration of a single intramuscular (IM) injection of FLUVIRIN® in non-elderly adult and elderly subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects eligible for enrollment into this study are male and female adult volunteers who are:
1. 18 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 good health as determined by: · medical history · physical examination · clinical judgment of the investigator
Informed consent must be obtained for all the subjects before enrollment in the study.
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E.4 | Principal exclusion criteria |
Individuals are not to be enrolled into the study if:
1. they have any serious disease such as: · cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy; · autoimmune disease (including rheumatoid arthritis); · advanced arteriosclerotic disease or insulin dependent diabetes mellitus; · chronic obstructive pulmonary disease (COPD) that requires oxygen therapy; · acute or progressive hepatic disease; · acute or progressive renal disease; · congestive heart failure; 2. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, thiomersal, 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 in: · receipt of immunosuppressive therapy (oral or parenteral corticosteroids, except topical or inhaled steroids 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; 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. women who are pregnant or lactating, or who refuse to undergo a pregnancy test, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 8. within the past 12 months, they have: · received more than one injection of influenza vaccine; 9. within the past 6 months, they have: · had laboratory confirmed influenza disease; · received influenza vaccine; 10. within the past 4 weeks they have received: · another vaccine; · any investigational agent; 11. within the past 7 days, they have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 12. they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days 13 within the past 3 days they have experienced: · fever (i.e., axillary body temperature ≥ 38°C); 14. they are taking part in another clinical study; 15. they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
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E.5 End points |
E.5.1 | Primary end point(s) |
The measures of immunogenicity for each antigen are: · the geometric mean titer (GMT) on Day 0 and Day 21 · the Day 21/Day 0 geometric mean titer ratios (GMR) · the percentage of subjects achieving seroconversion* or significant increase in antibody titer** · the percentage of subjects achieving an HI titer ≥ 40 on Day 0 and on Day 21
* Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination titer ≥40. ** Significant increase in antibody titer is defined as at least a fourfold increase in HI titer from non-negative pre-vaccination serum (≥10).
To assess the immunogenicity study objective, at least one of the following assessments should meet the indicated requirements for each strain: • Non-elderly adult subjects 18-60 years (i.e., ≥ 18 and < 61) - number of seroconversions* or significant increase in antibody titer** > 40% - mean geometric increase > 2.5 - the proportion of subjects achieving an HI titer ≥40, should be > 70% • Elderly subjects 61 years and older (i.e., ≥ 61) - number of seroconversions* or significant increase in antibody titer** > 30% - mean geometric increase > 2.0 - the proportion of subjects achieving an HI titer ≥40 should be > 60%
* Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination titer ≥40. ** Significant increase in antibody titer is defined as at least a fourfold increase in HI titer from non-negative pre-vaccination serum (≥10).
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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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End of Trial: corresponds to the last visit of the last subject undergoing the trial (LSLV). |
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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 | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |