| 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 |
Immunogenicity Objectives:
To evaluate the magnitude of antibody responses to one 0.5 mL intramuscular (IM) dose of Aflunov given before or after one 0.5 mL intramuscular (IM) dose of a tetravalent vaccine or after a concomitant administration in different sites of Aflunov and a licensed seasonal trivalent influenza vaccine.
To evaluate cell-mediated immunity (CMI, i.e.: frequency and functional phenotype of Ag-specific T and frequency of Ag-specific B lymphocytes) after one 0.5 mL intramuscular (IM) injection of Aflunov or a tetravalent vaccine. Cell-mediated immunity will be performed in a subgroup of 30 subjects.
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| E.2.2 | Secondary objectives of the trial |
Safety Objectives:
To evaluate the safety of the administration of one 0.5 mL intramuscular (IM) dose of Aflunov given before or after one 0.5 mL intramuscular (IM) dose of a tetravalent vaccine or after a concomitant administration in different sites of Aflunov and a licensed seasonal trivalent influenza vaccine. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Inclusion Criteria:
1. Subjects 18 years of age and above.
2. Subjects who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol;
3. Good health as determined by:
a. Medical history,
b. Physical examination,
c. Clinical judgment of the Investigator;
4. Subjects able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
Informed consent must be obtained for all the subjects before enrollment into the study.
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| E.4 | Principal exclusion criteria |
Exclusion Criteria:
1. Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study (which includes receipt of an investigational agent) through the end of the study;
2. Receipt of influenza vaccination for current season 2007/2008;
3. Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
4. Experienced fever (defined as axillary temperature ≥38.0°C) within 3 days prior to Visit 1;
5. Pregnant or breastfeeding;
6. Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
7. Any serious disease, such as:
a. Cancer (status after cancer declared healed is acceptable),
b. Autoimmune disease (including rheumatoid arthritis, except Hashimoto thyreoditis and Vitiligo),
c. Diabetes mellitus (insulin dependent),
d. Chronic pulmonary disease,
e. Acute or progressive hepatic disease,
f. Acute or progressive renal disease;
8. Major surgery planned during the study period (i.e. blood replacement expectable);
9. Bleeding diathesis;
10. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the study vaccine;
11. Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination;
12. History of any neurological disorder or seizure (e.g., GBS, MS);
13. Anaphylactic shock following administration of any vaccine;
14. Known or suspected impairment/alteration of immune function, for example, resulting from:
a. Receipt of immunosuppressive therapy (any systemic corticosteroid therapy or cancer chemotherapy; asthma under inhalative therapy only is permitted),
b. Receipt of immunostimulants,
c. High risk for developing an immunocompromising disease;
15. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
16. History of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
17. Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The measures of immunogenicity, collected for all evaluable subjects include:
- Geometric mean titers/areas (GMTs/GMAs) and geometric mean ratios (GMRs) as determined by HI (and SRH or MN in subsets).
- Percentage of subjects achieving seroconversion or significant increase in antibody titer/area as measured by HI (and SRH).
- Percentage of subjects with titers ≥20, titers ≥40, titers ≥80, at least a four-fold rise in titer at days after immunization as determined by MN.
- Percentage of subjects achieving a titer ≥40/ area ≥25 mm2 after immunization as determined by HI (and SRH)
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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 | No |
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
| 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 | Yes |
| 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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| last subject last visit, here by phone call |
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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 | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
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