Influenza MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Immunose™ FLU 1%
quadrivalent inactivated split influenza antigen 30 µg HA/strain, 1% Endocine
Pharmaceutical Form: Nasal drops
Pharmaceutical form of the placebo: Nasal drops
quadrivalent inactivated split influenza antigen 30 µg HA/strain, 2% Endocine
Pharmaceutical Form: Nasal drops
Pharmaceutical form of the placebo: Nasal drops
quadrivalent inactivated split influenza antigen 30 µg HA/strain, 2% Endoc
Pharmaceutical Form: Nasal drops
Pharmaceutical form of the placebo: Nasal drops
quadrivalent inactivated split, 30 µg HA/strain
Pharmaceutical Form: Nasal drops
Pharmaceutical form of the placebo: Nasal drops
Route of administration
quadrivalent inactivated split influenza antigen 15 µg HA/strain
Pharmaceutical Form: Injection
Sponsors
Eurocine Vaccines AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study related procedures. 2. Male or female 50-75 years of age (both inclusive) at screening. 3. Subjects who the Investigator believes will comply with the requirements of the protocol. 4. Judged by the Investigator to have no serious illness based on medical history, physical examination, ECG, vital signs and blood and urine assessments at screening. 5. All females should have been post-menopausal for at least 12 months or use a highly effective contraceptive method to prevent pregnancy. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Diagnosis of laboratory-confirmed influenza in the 2017/2018 season. 2. Use of any investigational drug product within 3 months before screening or planned use during the study period, including the safety follow-up period. 3. Administration of an influenza vaccine during the 9 months before screening. 4. Previously received another vaccine within 28 days before administration of the study vaccine, or is scheduled to receive another vaccine during the study period, excluding the safety follow-up period. 5. Any contra-indication to intramuscular administration of the influenza vaccine Influsplit Tetra (Fluarix Tetra) according to its SPC. 6. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to eggs or egg product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin, gentamycin, neomycin sulphate, formaldehyde and sodium deoxycholate). 7. Diagnosis of asthma with poor disease control as assessed by the Investigator. 8. Potent immunosuppressive therapy including cytostatics, antibodies, drugs acting on immunophilins, interferons and other drugs used to prevent rejection of organ transplants, within 6 months before screening. 9. Use of any parenteral or oral corticosteroids within 30 days prior to screening. Inhaled steroids are allowed. 10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 11. Any progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome. 12. Any history of Guillain-Barré syndrome. 13. Received blood, blood products and/or plasma derivatives or any administration of immunoglobulin preparation within the 3 months prior to Visit 2, or planned during the study. 14. Participation in blood donation within 3 months or plasma donation within 1 month prior to Visit 2. 15. History of substance or alcohol abuse within the past 2 years. 16. History or any illness/condition 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. 17. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or HIV. 18. Pregnant or lactating female or intent to become pregnant during the clinic phase and for 2 months after the last vaccination. 19. History of Bell’s palsy. 20. Ongoing regular use of intranasal sprays including corticosteroids and decongestants. 21. Ongoing cough, sinusitis, allergic rhinitis, nasal polyps or obstruction, including septum deviation significant enough to prevent bilateral administration of study vaccine. 22. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 23. Subjects that are prone to nosebleed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens in older adults (50 to 75 years).; Secondary Objective: To evaluate the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens in older adults by measurement of haemagglutination-inhibition (HI), virus neutralization (VN) and single radial haemolysis (SRH) titres in serum, and immunoglobulin A (IgA) titers in nasal secretions. ; Primary end point(s): 1. Type and incidence of AEs and SAEs from the time of first study drug administration (Visit 2) until the last visit to the clinic (Visit 4 for group 1 to 6 and Visit 3 for group 7). 2. Type and incidence of SAEs and AEs of special interest during the 6 months safety follow-up. 3. Frequency and severity of discomfort in the nose and throat and/or arm before study drug administration and 15, 30, 60 and 120 minutes after study drug administration. Discomfort in the nose and throat (group 1-6) and/or arm (group 6-7) will be assessed using a non-graded 100 mm visual analogue scale (VAS). 4. Frequency of clinically significant changes in ECG, vital signs, physical examination findings and laboratory variables from baseline to the last visit to the clinic. ; Timepoint(s) of evaluation of this end point: 1. Visit 2 and until the last visit to the clinic (Visit 4 for group 1 to 6 and Visit 3 for group 7). 2. During the 6 months safety follow-up. 3. Before study drug administration and 15, 30, 60 and 120 minutes after study drug administration. 4. From baseline to the last visit to the clinic. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Measurement of HI in blood, including: - Geometric mean titres (GMTs) and pre-/post-treatment ratios (GMRs) - Percentage of subjects with seroprotection (i.e., an HI titre =40) at pre-treatment and 21 days after each treatment. - Percentage of subjects with seroconversion (i.e., either a pre-treatment HI titre 25 mm2) at pre-treatment and 21 days after each treatment. - Percentage of subjects with seroconversion (i.e., either a negative pre-treatment serum (<4 mm2) and a positive post-treatment serum [area =25 mm2] or a significant increase in antibody titre i.e. at least a 50% increase in post-treatment area if pre-treatment is not negative). 4. Measurement of influenza-specific IgA in nasal secretions (pre-treatment and 21 days after each treatment) - GMTs and pre-/post-treatment GMRs - Percentage of subjects with a 2-fold, 4-fold and 8-fold increase in influenza-specific IgA ; Timepoint(s) of evaluation of this end point: 1. At pre-treatment and 21 days after each treatment. 2. At pre-treatment and 21 days after each treatment. 3. At pre-treatment and 21 days after each treatment. 4. At pre-treatment and 21 days after each treatment. | — |
Countries
Sweden
Contacts
Public ContactMartin Venge
PCG Clinical Services AB
Outcome results
None listed