Influenza
Conditions
Interventions
Trade Name: Fluad
Product Name: Fluad
Product Code: V70
Pharmaceutical Form: Suspension for injection
Product Name: Fluzone
Pharmaceutical Form: Suspension for injection
Sponsors
Novartis Vaccines and Diagnostics Srl.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of 6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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, g. acute or progressive neurological or neuromuscular disease; 2. History of any anaphylaxis or serious reaction following administration of vaccine, or 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; 3. 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 Visit 1, b. cancer chemotherapy, c. receipt of immunostimulants within 60 days prior to Visit 1, d. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, e. known HIV infection or HIV-related disease; 4. History of Guillain-Barré syndrome; 5. Bleeding diathesis; 6. Surgery planned during the study period; 7. Receipt of another investigational agent within 90 days, 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; 8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1; 9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1; 10. Ever received two doses of an influenza vaccine before the study, either in two consecutive influenza seasons or in one single influenza season; 11. Receipt of an influenza vaccine within 6 months prior to Visit 1; 12. Experienced a temperature =38.0°C (=100.4°F ) and/or any acute illness within 3 days prior to Visit 1; 13. 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: To evaluate the immunogenicity of two 0.25 mL IM doses of Fluad or Fluzone influenza vaccines in terms of post-vaccination geometric mean titers (GMTs), seroprotection rates and seroconversion rates, as measured by HI assay in subjects aged between 6 to <36 months, 36 to <60 months and 6 to <60 months. To evaluate the safety and tolerability of one and two 0.5 mL IM doses of Fluad or Fluzone influenza vaccines in unprimed healthy children aged between 6 to <36 months, 36 to <60 months and 6 to <60 months.;Secondary Objective: Not Applicable;Primary end point(s): • Number and percentage of children with at least one local or systemic reaction between 1 and 7 days after any vaccine injection. • Number and percentage of children with at least one AE between ay 1 and ay 50. • Number and percentage of subjects with at least one SAE or one AE necessitating a physician’s visit or consultation and/or leading to study discontinuation between Day 1 and study termination (day 211). • GMTs at Day 1, and Day 29; • Day 29/Day 1 and Day 50/Day 1 geometric mean titer ratios (GMRs); • percentage of children achieving seroconversion1 at Day 29; • percentage of children achieving seroprotection2 at Day 1, and at Day 29.;Timepoint(s) of evaluation of this end point: • Number and percentage of children with at least one local or systemic reaction between 1 and 7 days after any vaccine injection. • Number and percentage of children with at least one AE between ay 1 and ay 50. • Number and percentage of subjects with at least one SAE or one AE necessitating a physician’s visit or consultation and/or leading to study discontinuation between Day 1 and study termination (day 211). • GMTs at Day 1, and Day 29; • Day 29/Day 1 and Day 50/Day 1 geometric mean titer ratios (GMRs); • percentage of children achieving seroconversion1 at Day 29; • percentage of children achieving seroprotection2 at Day 1, and at Day 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
United States
Contacts
Public ContactPosting Director
Novartis Vaccines and Diagnostics Srl.
Outcome results
None listed