Prophylaxsis of seasonal influenza MedDRA version: 12.0 Level: HLT Classification code 10022005 Term: Influenza viral infections
Conditions
Interventions
Product Code: SLV203
Pharmaceutical Form: Suspension for injection
Current Sponsor code: SLV203
Other descriptive name: Influvac vaccine (surface antigen, inactivated, prepared in cell cultures)
Conce
Sponsors
Abbott Biologicals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male subjects > 61 years of age. 2. Willing and able to give informed consent before any protocol procedures are performed. 3. Able to adhere to visit schedules and all protocol required study procedures. 4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been unchanged for at least 3 months preceding study vaccination). 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. Seasonal influenza vaccination or laboratory confirmed seasonal influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination (seasonal or novel Influenza A (H1N1)) within three weeks of study vaccination. 2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator. 3. A serious adverse reaction after a previous vaccination, including influenza vaccination. 4. A history of Guillain-Barré syndrome. 5. Known to be allergic to constituents of the study vaccines. 6. Fever and/or presence of an acute infectious episode of the upper and/or lower respiratory airways. Fever is defined as an oral temperature of = 38ºC. Enrollment can be postponed until a subject has been a febrile for 72 hours. 7. Being a solid organ or bone marrow/stem cell transplant recipient. 8. Use of immune system modulators including: systemic corticosteroids, immunosuppressive agents such as cyclosporine, intravenous monoclonal antibodies and intravenous or intramuscular gamma-globulin preparations within four weeks of study vaccination or if planned for use any time during the study. Topical use of corticosteroids (e.g. cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the package insert, is allowed. 9. Chronic diseases requiring long-term immunosuppressive therapy. 10. Receipt of another investigational product within 90 days prior to entering this study (date of informed consent), participating in the long-term follow-up of another clinical trial, unwilling to refuse to participate in another clinical trial during the current clinical study. 11. Known drug or alcohol abuse. 12. Blood or plasma transfusions received within three months of study vaccination. 13. Vaccination with a live vaccine or a killed/inactivated vaccine in the four weeks prior to study vaccination. 14. Being an employee of the Sponsor/CRO conducting this study or personnel of the study site. 15. During the second year of the study only: History of vaccination with a seasonal influenza vaccine following initial study vaccination on studies Day 1 (Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate in elderly subjects (> 61 years of age) that three weeks after the first vaccination the cell-derived influenza vaccine meets all three of the Committee for Medicinal Products for Human Use (CHMP) criteria for influenza vaccine immunogenicity for the three strains in the vaccine. ;Secondary Objective: 1) To assess in the elderly subjects one year following the initial vaccination, whether three weeks after revaccination with the cell-derived influenza vaccine all three CHMP criteria for influenza vaccine immunogenicity are met for all three strains in the vaccine. 2) To assess in elderly subjects during the first year the long-term immunogenicity of the cell-derived influenza vaccine six months following the initial vaccination.;Primary end point(s): The primary immunogenicity endpoints will be the serum haemagglutination inhibition antibody (HI) titers measured the same day as but prior to vaccination as well as three weeks after vaccination. From these measurements, seroprotection rates, seroconversion rates, and mean fold increases will be derived. In addition, HI titers are to be measured six months after the initial vaccination. | — |
Countries
Czech Republic, Estonia, Lithuania
Outcome results
None listed