pandemic influenza
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
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; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Safety Objectives • To evaluate the safety and tolerability profile of FLUAD-H5N1 compared with a MF59-adjuvanted interpandemic trivalent influenza vaccine (FLUAD). ;Primary end point(s): see E.2.1 and E.2.2 | — |
Countries
Finland, Germany
Outcome results
None listed