Pandemic influenza
Conditions
Interventions
Trade Name: Focetria
Product Name: Focetria
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Other descriptive n
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 years of age and above on the day of enrollment; 2. Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator 3. Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study 4. 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? 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. Individuals 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 (including, but not limited to 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. 5. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1; 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 participation in another clinical study through the end of this study; 7. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 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 degrees Celsius (= 100.4° F) or oral temperature = 38.5 (=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 neurological disorders (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions); 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 or pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy. b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) ii. Barrier (condom with spermicide or diaphragm with spermic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the preferred vaccine formulation (with and without MF59), dosage (of antigen and adjuvant) and schedule (one or two administrations) of the egg-derived H1N1sw monovalent vaccine in healthy adults based on CHMP criteria and pairwise statistical comparisons for immunogenicity, and safety & tolerability.;Secondary Objective: Immunogenicity objectives 1. To evaluate immunogenicity of a booster dose of the egg-culture 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 inhibition (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 adult and elderly population. Safety objectives To evaluate safety and tolerability of the egg-derived H1N1sw monovalent vaccine for 3 weeks after first and second vaccination To evaluate safety and tolerability of the egg-derived H1N1sw monovalent vaccine up to 6 months after the last (booster) vaccination.;Primary end point(s): 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: For adults subjects aged 18-60 years: • The percentage of subjects with seroconversion or significant increase in HI antibody is > 40% • The percentage of subjects achieving an HI titer =40 is > 70% • The GMR is >2.5 For elderly subjects aged =61 years: • The percentage of subjects with seroconversion or at significant increase in HI antibody is > 30% • The percentage of subjects achieving an HI titer =40 is > 60% • The GMR is >2.0 All three criteria should be met within in each age group to fulfill regula | — |
Countries
Germany, Netherlands
Outcome results
None listed