seasonal influenza MedDRA version: 9.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Agrippal
Product Name: TIV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/Brisbane/59/2007 (H1N1) - like strain, (A/Brisbane/59/2007, IVR-148)
Concentration unit: µ
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment into this study are: 1. Children of 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any history of serious disease, such as: a. cancer b. autoimmune disease (including rheumatoid arthritis), c. diabetes mellitus, d. chronic pulmonary disease (including severe reactive airway disease) e. acute or progressive hepatic disease, f. acute or progressive renal disease, g. acute or progressive neurological or neuromuscular disease; 2. History of any anaphylaxis or serious reaction following administration of vaccine 3. History of hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials; 4. Known or suspected impairment/alteration of immune function, including: a. immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visits 1 and 3, b. any history of cancer chemotherapy, c. receipt of immunostimulants within 60 days prior to Visits 1 and 3, d. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivatives within 3 months prior to Visits 1 and 3 or planned during the full length of the study, e. known HIV infection or HIV-related disease; 5. History of Guillain-Barré syndrome; 6. History of non-febrile seizures 7. History of or clinically suspected developmental delay 8. Bleeding diathesis; 9. Surgery planned during the study period; 10. Receipt of another investigational agent within 90 days of Visit 1, or before completion of the safety follow-up period in another study, whichever is longer. 11. Unwilling to refuse participation in another clinical study through the end of the study; 12. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1; 13. Laboratory-confirmed influenza disease within 6 months prior to Visit 1; 14. Ever received two doses of an influenza vaccine before the study, either in two consecutive influenza seasons or in one single influenza season; 15. Receipt of an influenza vaccine within 6 months prior to Visit 1; 16. Experienced a rectal temperature ?38.5°C, fever as defined by Table 4 , and/or any acute illness within 3 days prior to Visits 1 and 3; 17. Any condition, which in the opinion of the Investigator would preclude the subject, on a medical basis, from enrollment or that might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate safety and tolerability of the study vaccines described below as compared to one and two 0.25 mL IM doses of trivalent inactivated influenza vaccine (TIV) and as compared to a marketed trivalent inactivated influenza vaccine: A. One and/or two 0.25 or 0.50 mL IM doses of quadrivalent influenza vaccine (TIV formulated with a second B strain; hereafter referred to as QIV). B. One and/or two 0.25 or 0.50 mL IM doses of TIV formulated with no dose, eighth dose, quarter dose, half dose, or full dose of adjuvant (MF59). C. One and/or two 0.25 or 0.50 mL IM doses of QIV formulated with either 0, quarter dose, half dose, or full dose of adjuvant (MF59). in unprimed healthy children aged 6 months to <36 months. Safety will be evaluated by collection of spontaneously reported adverse events (AEs) and tolerability will be evaluated by collection of solicited injection site reactions and solicited systemic reactions;Secondary Objective: Immunogenicity -identify non-inferior study vaccine formulations with a lower MF59 content than in pediatric doses of TIV with half dose MF59, as assessed by immunogenicity -identify study vaccine formulations that are superior to pediatric doses of TIV with half dose MF59 -identify vaccine combination that are superior to pediatric doses of a marketed comparator trivalent influenza vaccine -evaluate whether a one-dose schedule provide a similar immunogenicity as a two-dose schedule -evaluate whether the addition of a 2nd influenza B strain increases the antibody responses to this same influenza B strain -determine whether the addition of a 2nd influenza B strain to a TIV vaccine increases cross-reactive seroprotection against A/H3N2, A/H1N1 and the 1st influenza B strain, as assessed 3 to 4 weeks post final IM injection;Primary end point(s): Main objectives will be tested using homologous strain-specific antibodies assessed 4 weeks post 1st (Day 29)and 3 weeks post 2nd IM (Day 50) vaccination. In addition, antibody ti | — |
Countries
Belgium, Finland
Outcome results
None listed