avian influenza
Conditions
Interventions
Product Name: Fluad H5N1
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus surface antigens (HA andn NA), H5N1 (A/Vietnam/1194/2004 NIBRG-14)
Concentration unit: µg
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co. KG
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; 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) 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. Receipt of influenza vaccination for current season 2006/2007. 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 (including rheumatoid arthritis) 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, 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 or cancer chemotherapy) b. receipt of immunostimulant c. high risk for developing an immunocompromising disease 13. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination 14. 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 15. Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile of FLUAD-H5N1 and to rule out an occurrence of an AE with a rate of 0.1% in Adults and 1% in Elderly subjects;Secondary Objective: To evaluate the safety profile of FLUAD-H5N1 when compared to the interpandemic influenza vaccine FLUAD To evaluate the magnitude of antibody responses to two doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine, each containing 7.5 mg of H5N1 antigen;Primary end point(s): Number and percentage of subjects with at least one local reaction between 1 and 7 days after each vaccine injection. Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after each vaccine injection. Number and percentage of subjects with at least one adverse event between day 1 and the study termination visit. The measures of immunogenicity, collected for all evaluable subjects include: - geometric mean titers/areas (GMTs/GMAs) and GMRs at Days 1, 22, and 43 as determined by HI, SRH, and MN. - percentage of subjects achieving seroconversion or significant increase in antibody titer/area at Days 22, and 43 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 22, and 43 as determined by MN. - percentage of subjects achieving a titer =40/ area =25 mm2 at Days 22, and 43 as determined by HI and SRH. | — |
Countries
Czech Republic, Lithuania
Outcome results
None listed