| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
Safety Objectives
• To assess the safety and tolerability profile of two doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (FLUAD-H5N1), each containing 7.5 µg of H5N1 antigen.
• To contribute to an integrated safety database of approximately 3300 subjects exposed to FLUAD-H5N1, capable of detecting rare adverse events in adult subjects, i.e. events that occur at a frequency of <=0.1%, and uncommon adverse events in elderly, i.e. that occur at a frequency of <=1%.
Immunogenicity Objectives
• To evaluate the immunogenicity of two doses of FLUAD-H5N1, each containing 7.5 µg of H5N1 antigen, versus the homologous A/Vietnam/1194/2004 strain.
• To evaluate the immunogenicity of two doses of FLUAD-H5N1, each containing 7.5 µg of H5N1 antigen, versus the heterovariant A/turkey/Turkey/1/2005 strain.
|
|
| E.2.2 | Secondary objectives of the trial |
Safety Objectives
• To evaluate the safety and tolerability profile of FLUAD-H5N1 compared with a MF59-adjuvanted interpandemic trivalent influenza vaccine (FLUAD).
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects 18 years of age and older who are mentally competent and who have
signed an informed consent form after having received a detailed explanation of
the study protocol;
2. In good health as determined by:
a. medical history,
b. physical examination,
c. clinical judgment of the Investigator;
3. Able to understand and comply with all study procedures and to complete study
diaries, can be contacted, and will be available for study visits;
|
|
| E.4 | Principal 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 through
the end of the study;
2. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
3. Receipt of influenza vaccination for current season 2008/2009;
4. Experienced any acute disease or infection requiring systemic antibiotic or
antivira therapy (chronic antibiotic therapy for urinary tract prophylaxis is
acceptable) within the past 7 days;
5. Experienced fever (defined as axillary temperature >=38.0°C) within 7 days prior
to Visit 1;
6. Pregnant or breastfeeding;
7. Females of childbearing potential who are sexually active and have not used or do
not plan or refuse to use an acceptable method of birth control during the active
phase of the study (at least up to three weeks after last vaccine
injection). Adequate contraception method is defined as hormonal (e.g., oral,
injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or
diaphragm with spermicidal agent), and intrauterine device (e.g., IUD);
8. Any serious disease, such as:
a. cancer except for:
i. benign or localized skin cancer
ii. localized prostate cancer that has been clinically stable for ≥ 2
years without treatment
iii.cancer in remission for ≥ 10 years
b. autoimmune disease (including rheumatoid arthritis) except for Hashimoto's
thyroiditis that has been clinically stable for ≥ 5 years;
c. diabetes mellitus type I;
d. diabetes mellitus type II with haemoglobin A1C > 7.5%;
e. diabetes relating to genetic defects/syndromes, diseases of the exocrine
pancreas, or infections;
f.advanced arteriosclerotic disease including but not limited to: ischemic heart
disease (e.g., angina), prior history of myocardial infarction or cerebrovascular
accident (CVA), transient ischemic attacks, prior surgical/interventional
radiology intervention for arteriosclerotic disease (e.g., coronary artery
bypass graft, angioplasty, vascular stent placement, vascular graft
procedures), and claudication/rest pain;
g. severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and
4;
h. acute or progressive hepatic disease;
i. acute or progressive renal disease;
j. congestive heart failure;
k. Body Mass Index ≥35 kg/m2 where BMI reflects obesity and not high
muscle mass;
9. History of progressive or severe neurologic disorders including but not limited
to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, amyotrophic
lateral sclerosis, Creutzfeldt-Jakob disease, epilepsy disorders requiring
medication for control, encephalitis, Alzheimer's and CVA;
10. Surgery planned during the study period;
11. Bleeding diathesis;
12. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza
viral protein, neomycin or polymyxin or any other component of
the study vaccines;
13. History of any neurological symptoms or signs, or 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 corticosteroid therapy or cancer
chemotherapy) or other immunosuppressive agents within the past 60 days
and for the full length of the study;
b. receipt of immunostimulants;
c. receipt of parenteral immunoglobulin preparation, blood products
and/or plasma derivates within the past 3 months and for the full length of
the study;
d. suspected or known HIV infection or HIV-related disease;
15. Receipt of non study vaccines (with the exception of post-exposure vaccination
in a medical emergency, e.g. hepatitis, rabies, tetanus) 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. Members of research staff and their relatives;
18. Any condition, which, in the opinion of the Investigator, might interfere with the
evaluation of the study objectives.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
|
| 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| 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 |
|
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 26 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| 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
| |
| 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 | 11 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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