Pandemic influenza
Conditions
Interventions
Trade Name: Focetria
Product Name: Focetria
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Other descriptive nam
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 6 months of age to 17 years of age on the day of enrollment; 2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable, after the nature of the study has been explained according to local regulatory requirementsable to comply with all study procedures and requirements; 3. Individuals in good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator; 4. Subjects, subject's parents or legal guardians that are able to comply with all study procedures and are available for all clinic visits scheduled in the study. 5. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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. Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study; 2. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 3. Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 4. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), chicken protein; 5. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1. “Documented-confirmed” includes: a. Positive serology result b. Positive viral culture c. Positive rapid antigen test d. “Suspected” influenza disease includes: subjects with influenza-like illness within the past 3 months with a household/intimate contact with “laboratory-confirmed” influenza disease; 6. Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study; 7. Individuals who receive any other vaccine 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within four weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until one week prior to and after one week study vaccinations 8. Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks; 9. Individuals with axillary temperature = 38.0 degrees Celsius (=100.4 F) or oral/rectal temperature = 38.5 degrees Celsius(=101.3 F) within 3 days of intended study vaccination; 10. Known or suspected impairment/alteration of immune function, for example resulting from: a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800µg/day or fluticasone 750µg/day) 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; 11. History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsion, but excluding febrile convulsion); 12. History of or clinically suspected developmental delay; 13. Bleeding diathesis; 14. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule; 15. If female, of childbearing potential, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry: a. Female of childbearing potential is defined as a post onset of menarche capable of becoming pregnant and not surgically sterile b. Acceptable birth control methods are defined as one
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the preferred vaccine formulation (with or without MF59), dosage (of antigen and adjuvant) and schedule (one or two administrations) of the egg-derived H1N1sw monovalent vaccine in healthy children and adolescents based on CHMP criteria and pairwise statistical comparisons for immunogenicity, safety and tolerability.;Secondary Objective: Immunogenicity objectives 1. To evaluate immunogenicity of a booster dose of the egg-derived H1N1sw monovalent influenza vaccine administered 12 months after the primary course with respect to CHMP criteria. 2. To evaluate the non-inferiority of the post-vaccination (Day 43) hemagglutination hinibition (HI) geometric mean titer (GMT) of the half dose (3.75 µg of HA + half MF59) of the egg derived H1N1sw monovalent vaccine to the corresponding GMTs of the full dose (7.5 µg of HA + full MF59) of the egg derived H1N1sw monovalent vaccine, after two doses administered 3 weeks apart in the pooled children population. Safety objectives To evaluate safety and tolerability of the egg-derived H1N1sw monovalent vaccine for 3 weeks after the first and second vaccination. To evaluate safety and tolerability of the egg-derived H1N1sw monovalent vaccine for up to 6 months after the booster dose in the paediatric population.;Primary end point(s): Immunogenicity criteria for success for EU licensure will be based on CHMP requirements, even though these criteria apply to subjects =18 years of age (for the pediatric population, no CHMP criteria are defined). The immunogenicity criteria for success, as determined by HI, related to the EMEA/CPMP/VEG/4717/2003-Rev.1 (pandemic guideline) and EMEA/CHMP/VWP/263499/2006 (pre-pandemic guideline) are: • The percentage of subjects with seroconversion or at least 4-fold increase in HI antibody is > 40% • The percentage of subjects achieving an HI titer = 1:40 is > 70%. • The GMR is >2.5 All three criteria as assessed at Day 43 should be met within each age group to fulfill regulat | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed