Pandemic influenza
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 to 60 years of age 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 all study visits. Informed consent must be obtained for all the subjects before enrollment into the study. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any H5 vaccine; 2. 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; 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, b. Autoimmune disease, c. diabetes mellitus, d. chronic pulmonary disease, e. acute or progressive hepatic disease, f. acute or progressive renal disease; 8. Surgery planned during the study period; 9. Bleeding diathesis; 10. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine; 11. History of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine; 12. Known or suspected impairment/alteration of immune function, for example, resulting from: a. Receipt of immunosuppressive therapy (any corticosteroid therapy b. Receipt of immunostimulants, c. High risk for developing an immunocompromising disease; 13. Receipt of non study vaccine (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; 14. Body Mass Index above 35 kg/m2; 15. 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; 16. Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives; 17. Members of research staff and their relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the magnitude of antibody responses to two doses of FLUAD-H5N1 influenza vaccine, each containing 7.5µg of A/H5N1 antigen administered 1, 2, 3, or 6 weeks apart. To evaluate the safety and tolerability of two 0.5 mL intramuscular (IM) injections of FLUAD-H5N1 influenza vaccine containing 7.5µg of A/H5N1 influenza antigen.;Secondary Objective: ;Primary end point(s): see E.2.1 | — |
Countries
Czech Republic
Outcome results
None listed