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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunose™ FLU 1% | Experimental | Immunose™ FLU 1%. QIV, 30 μg HA/strain and 1% Endocine™ 200 μl for intranasal administration, 2 dosing occasions. |
|
| Immunose™ FLU 2%, 200 μl | Experimental | Immunose™ FLU 2%. QIV, 30 μg HA/strain and 2% Endocine™, 200 μl for intranasal administration, 2 dosing occasions. |
|
| Immunose™ FLU 2%, 300 μl | Experimental | Immunose™ FLU 2%, 300 μl. QIV, 30 μg HA/strain and 2% Endocine™, 300 μl for intranasal administration, 2 dosing occasions. |
|
| Influenza antigen | Experimental | Influenza antigen. QIV, 30 μg HA/strain, 200 μl for intranasal administrations, 2 dosing occasions. |
|
| Placebo | Placebo Comparator | Placebo. Saline (NaCl), 200 μl for intranasal administration, 2 dosing occasions. |
|
| i.m comparator and Immunose™ FLU 2% |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunose™ FLU 1% | Biological | Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Day 180 |
| Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Day 0) |
| Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Rein Hedin, MD | CTC Clinical Trial Consultants AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 5 | Borås | Sweden | ||||
| Site 4 |
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| Experimental |
i.m comparator: QIV 15 μg HA/strain, 500 µl for a single intramuscular administration, and Immunose FLU 2%: QIV 30 μg HA/strain and 2% Endocine™, 200 μl for intranasal administration. A second dose of Immunose FLU 2% will be administered 3 weeks later. |
|
| i.m comparator | Active Comparator | i.m comparator. QIV 15 μg HA/strain, 500 µl for a single intramuscular administration. |
|
| Immunose™ FLU 2%, 200 μl | Biological | Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2 |
|
| Immunose™ FLU 2%, 300 μl | Biological | Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2 |
|
| Influenza antigen | Biological | Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2 |
|
| Placebo | Drug | NaCl dosing volume 200 μl, intranasal administration x 2 |
|
|
| i.m comparator | Biological | Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1 |
|
Type and incidence of AEs and SAEs of special intrerest. Treatment group 1-6. |
| Day 201 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Visit 1 (Day -42 to -1) to Visit 3 (Day 21) |
Measurement of HaemaggIutination-inhibition titers in serum. Treatment group 1-7. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Visit 4 (Day 42) |
| Helsingborg |
| Sweden |
| Site 2 | Linköping | Sweden |
| Site 3 | Malmö | Sweden |
| Site 1 | Uppsala | Sweden |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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