This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5), parallel-group study designed to primarily evaluate the safety, tolerability and immune response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The hypothesis is that Immunose™ FLU is safe and tolerable and will increase the influenza-specific mucosal immune response in older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
298
Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2
Site 5
Borås, Sweden
Site 4
Helsingborg, Sweden
Site 2
Linköping, Sweden
Site 3
Malmo, Sweden
Site 1
Uppsala, Sweden
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Type and incidence of AEs and SAEs. Treatment group 1-7.
Time frame: Visit 2 (Day 0)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Type and incidence of AEs and SAEs. Treatment group 1-7.
Time frame: Visit 3 (Day 21)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Type and incidence of AEs and SAEs. Treatment group 1-6.
Time frame: Visit 4 (Day 42)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Type and incidence of AEs and SAEs of special intrerest. Treatment group 7.
Time frame: Day 90
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Type and incidence of AEs and SAEs of special intrerest. Treatment group 1-6.
Time frame: Day 111
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Type and incidence of AEs and SAEs of special intrerest. Treatment group 7.
Time frame: Day 180
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Type and incidence of AEs and SAEs of special intrerest. Treatment group 1-6.
Time frame: Day 201
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Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2
NaCl dosing volume 200 μl, intranasal administration x 2
Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Frequency and severity of discomfort in the nose and/or throat before study drug administration and at 15, 30, 60 and 120 minutes after study drug administration. Treatment group 1-5.
Time frame: Visit 2 (Day 0)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Frequency and severity of discomfort in the nose and/or throat and/or arm before study drug administration and at 15, 30, 60 and 120 minutes after study drug administration. Treatment group 6.
Time frame: Visit 2 (Day 0)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Frequency and severity of discomfort in the arm before study drug administration and at 15, 30, 60 and 120 minutes after study drug administration. Treatment group 7.
Time frame: Visit 2 (Day 0)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Frequency and severity of discomfort in the nose and/or throat before study drug administration and at 15, 30, 60 and 120 minutes after study drug administration. Treatment group 1-6.
Time frame: Visit 3 (Day 21)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in ECG. Treatment group 1-6.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in ECG. Treatment group 7.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in vital signs. Treatment group 1-6.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in vital signs. Treatment group 7.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in physical examination findings. Treatment group 1-6.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in physical examination findings. Treatment group 7.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in laboratory variables. Treatment group 1-6.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Frequency of clinically significant changes in laboratory variables. Treatment group 7.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of HaemaggIutination-inhibition titers in serum. Treatment group 1-7.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of HaemaggIutination-inhibition titers in serum. Treatment group 1-7.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of HaemaggIutination-inhibition titers in serum. Treatment group 1-6.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Virus Neutralization titers in serum. Treatment group 1-7.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Virus Neutralization titers in serum. Treatment group 1-7.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Virus Neutralization titers in serum. Treatment group 1-6.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Single Radial Haemolysis titres in serum. Treatment group 1-7.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Single Radial Haemolysis titres in serum. Treatment group 1-7.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Single Radial Haemolysis titres in serum. Treatment group 1-6.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Immunoglobulin A (IgA) titers in nasal secretion. Treatment group 1-7.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Immunoglobulin A (IgA) titers in nasal secretion. Treatment group 1-7.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Measurement of Immunoglobulin A (IgA) titers in nasal secretion. Treatment group 1-6.
Time frame: Visit 4 (Day 42)