avian influenza MedDRA version: 9.1 Level: LLT Classification code 10064097 Term: Avian influenza
Conditions
Interventions
Product Name: FLUAD-H5N1
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus surface antigen (HA and NA), H5N1 (A/Vietnam/1194/2004 NIBRG-14)
Concentration unit: µg m
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male subjects aged 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study at the same time or within the last 3 months and unwilling to refuse participation in another clinical study through the end of this study; 2. Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant; 3. Receipt of influenza vaccination for the current season 2007/2008; 4. Receipt of another vaccine within 3 weeks before and after each study vaccination; 5. 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; 6. Fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1, 7. Pregnant or breastfeeding; 8. Females of childbearing potential (i.e., after first menstrual bleeding until 2 years after last menstrual bleeding, except females with hysterectomy or abstinent females) who refuse to use an acceptable method of birth control for the duration of the study and who refuse to perform a urine pregnancy test prior to vaccination. 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 a vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry; 9. Any serious disease, such as: a. Cancer, b. Autoimmune disease (including rheumatoid arthritis), c. Diabetes mellitus, d. Asthma, chronic pulmonary disease (steroids administered by inhalation only or clinical symptoms less frequent than once a day are acceptable), e. Acute or progressive hepatic disease, f. Acute or progressive renal disease; 10. Known or suspected impairment/alteration of immune function, for example, resulting from: a. Receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy, immunoglobulins), asthma under inhalation therapy only acceptable, b. Receipt of immunostimulants, c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, d. High risk for developing an immunocompromising disease; 11. Surgery planned during the study period; 12. Bleeding diathesis; 13. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine; 14. History of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 15. History of neurological disorder or seizures (febrile seizures allowed); 16. Children who are in the local recommendation for influenza vaccination; 17. 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; 18. 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 evaluate the safety and tolerability of and the magnitude of antibody responses to two 0.5mL intramuscular (IM) injections of FLUAD-H5N1 influenza vaccine each containing 7.5µg of A/H5N1 influenza antigen, administered 3 weeks apart.;Secondary Objective: To evaluate the safety and tolerability of one 0.5mL IM injection of FLUAD-H5N1 influenza vaccine containing 7.5µg of A/H5N1 influenza antigen, administered 12 months after the second dose. To evaluate the magnitude of antibody response to a 12 months booster dose of FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages. To evaluate the persistence of specific antibodies 12 months after primary immunization in subjects of different ages. To evaluate the cross-protection of a FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages. ;Primary end point(s): The measures of immunogenicity, collected for all evaluable subjects of the FLUAD-H5N1 group include: - Geometric mean titers/area (GMTs/GMAs) and geometric mean ratios (GMRs) on days 1, 22, and 43, 382 and day 403 as determined by HI, SRH, and MN. - Percentage of subjects achieving seroconversion or significant increase in antibody titer on days 22, 43, 382, and 403 as measured by HI and SRH. - Percentage of subjects with MN titers =1:20, =1:40, =1:80 on day 1, day 22, and day 43. - Percentage of subjects achieving at least a four-fold rise in antibody titer on days 22, 43, 382, and 403 as measured by MN. - Percentage of subjects achieving a titer =40/ area =25mm2 on days 22, 43, 382 and 403 as determined by HI and SRH. Number and percentage of subjects with at least one local reaction between day 1 and day 7 after each vaccine injection. Number and percentage of subjects with at least one systemic reaction between day 1 and day 7 days after each vaccine injection. Number and percentage of subjects with at least one adverse event between day 1 and day 43 or between | — |
Countries
Finland
Outcome results
None listed