InfluenzaPhase 1/2NCT03437304
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
A Phase 1/2 study testing Immunose™ FLU 1%, Immunose™ FLU 2%, 200 μl and Immunose™ FLU 2%, 300 μl in people with Influenza, run by Eurocine Vaccines AB at 5 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Immunose™ FLU 1%, Immunose™ FLU 2%, 200 μl and Immunose™ FLU 2%, 300 μl
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 5 sitesSweden
- Study dates
- 9 Feb 2018to 30 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study related procedures.
- Male or female 50 to75 years of age (both inclusive) at screening.
- Subjects who the Investigator believes will comply with the requirements of the protocol.
- 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.
- All females should have been post-menopausal for at least 12 months or use a highly effective contraceptive method to prevent pregnancy. Non-menopausal females have to use contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen- only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral tubal occlusion, sexual abstinence). Any male partner should be willing to use condom or should be vasectomized.
Who cannot join
- Diagnosis of laboratory-confirmed influenza in the 2017/2018 season.
- Use of any investigational drug product within 3 months before screening or planned use during the study period, including the safety follow-up period.
- Administration of an influenza vaccine during the 9 months before screening.
- 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.
- Any contra-indication to intramuscular administration of the comparator influenza vaccine according to its SPC.
- 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).
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- Diagnosis of asthma with poor disease control as assessed by the Investigator.
- 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.
- Use of any parenteral or oral corticosteroids within 30 days prior to screening. Inhaled steroids are allowed.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Any progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome.
- Any history of Guillain-Barré syndrome.
- 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.
- Participation in blood donation within 3 months or plasma donation within 1 month prior to Visit 2.
- History of substance or alcohol abuse within the past 2 years.
- 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.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or HIV.
- Pregnant or lactating female or intent to become pregnant during the clinic phase and for 2 months after the last vaccination.
- History of Bell's palsy.
- Ongoing regular use of intranasal sprays including corticosteroids and decongestants.
- Ongoing cough, sinusitis, allergic rhinitis, nasal polyps or obstruction, including septum deviation significant enough to prevent bilateral administration of study vaccine.
- Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Subjects that are prone to nosebleed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Site 5
Borås
Site 4
Helsingborg
Site 2
Linköping
Site 3
Malmö
Site 1
Uppsala
About this study
Official title: A Phase I/II, Randomised, Multicentre, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults (Age 50 to 75 Years)
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.
- Conditions
- Influenza
- Being tested
- Immunose™ FLU 1%, Immunose™ FLU 2%, 200 μl, Immunose™ FLU 2%, 300 μl, Influenza antigen, Placebo
- Keywords
- Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunose™ FLU 1%Biological
Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 200 μlBiological
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 300 μlBiological
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2
Influenza antigenBiological
Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2
PlaceboDrug
Also called Saline (NaCl)
NaCl dosing volume 200 μl, intranasal administration x 2
i.m comparatorBiological
Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
| Study group | Role | What they receive |
|---|---|---|
| Immunose™ FLU 1% | Experimental | Immunose™ FLU 1%. QIV, 30 μg HA/strain and 1% Endocine™ 200 μl for intranasal administration, 2 dosing occasions. Receives: Biological: Immunose™ FLU 1% |
| 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. Receives: Biological: Immunose™ FLU 2%, 200 μl |
| 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. Receives: Biological: Immunose™ FLU 2%, 300 μl |
| Influenza antigen | Experimental | Influenza antigen. QIV, 30 μg HA/strain, 200 μl for intranasal administrations, 2 dosing occasions. Receives: Biological: Influenza antigen |
| Placebo | Placebo comparator | Placebo. Saline (NaCl), 200 μl for intranasal administration, 2 dosing occasions. Receives: Drug: Placebo |
| i.m comparator and Immunose™ FLU 2% | 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. Receives: Biological: Immunose™ FLU 2%, 200 μl; Biological: i.m comparator |
| i.m comparator | Active comparator | i.m comparator. QIV 15 μg HA/strain, 500 µl for a single intramuscular administration. Receives: Biological: i.m comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 4 (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start9 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurocine Vaccines AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Rein Hedin, MD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437304
- Sponsor's protocol ID
- EURO 17-09
- Status last verified
- Dec 2018
- First submitted
- 5 Feb 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomised, Multicentre, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults (Age 50 to 75 Years)
- ClinicalTrials.gov ID
- NCT03437304
- Acronym / sponsor ID
- EURO 17-09
- Conditions
- Influenza
- Keywords
- Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Eurocine Vaccines ABIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Immunose™ FLU 1% | Experimental | Biological: Immunose™ FLU 1%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 | Biological: Immunose™ FLU 2%, 200 μlImmunose™ FLU 2%. QIV, 30 μg HA/strain and 2% Endocine™, 200 μl for intranasal administration, 2 dosing occasions. |
| Immunose™ FLU 2%, 300 μl | Experimental | Biological: Immunose™ FLU 2%, 300 μlImmunose™ FLU 2%, 300 μl. QIV, 30 μg HA/strain and 2% Endocine™, 300 μl for intranasal administration, 2 dosing occasions. |
| Influenza antigen | Experimental | Biological: Influenza antigenInfluenza antigen. QIV, 30 μg HA/strain, 200 μl for intranasal administrations, 2 dosing occasions. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo. Saline (NaCl), 200 μl for intranasal administration, 2 dosing occasions. |
| i.m comparator and Immunose™ FLU 2% | Experimental | Biological: Immunose™ FLU 2%, 200 μl, Biological: i.m comparatori.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 | Biological: i.m comparatori.m comparator. QIV 15 μg HA/strain, 500 µl for a single intramuscular administration. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent prior to any study related procedures.
- Male or female 50 to75 years of age (both inclusive) at screening.
- Subjects who the Investigator believes will comply with the requirements of the protocol.
- 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.
- All females should have been post-menopausal for at least 12 months or use a highly effective contraceptive method to prevent pregnancy. Non-menopausal females have to use contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen- only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral tubal occlusion, sexual abstinence). Any male partner should be willing to use condom or should be vasectomized.
Key exclusion criteria (23 listed)
- Diagnosis of laboratory-confirmed influenza in the 2017/2018 season.
- Use of any investigational drug product within 3 months before screening or planned use during the study period, including the safety follow-up period.
- Administration of an influenza vaccine during the 9 months before screening.
- 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.
- Any contra-indication to intramuscular administration of the comparator influenza vaccine according to its SPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunose™ FLU 1%Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2 | Biological | Immunose™ FLU 1% |
| Immunose™ FLU 2%, 200 μlQuadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2 | Biological | Immunose™ FLU 2%, 200 μl, i.m comparator and Immunose™ FLU 2% |
| Immunose™ FLU 2%, 300 μlQuadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2 | Biological | Immunose™ FLU 2%, 300 μl |
| Influenza antigenQuadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2 | Biological | Influenza antigen |
| PlaceboAlso: Saline (NaCl)NaCl dosing volume 200 μl, intranasal administration x 2 | Drug | Placebo |
| i.m comparatorQuadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1 | Biological | i.m comparator, i.m comparator and Immunose™ FLU 2% |
Primary outcome
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Time frame: Visit 2 (Day 0)
Type and incidence of AEs and SAEs. Treatment group 1-7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Time frame: Visit 3 (Day 21)
Type and incidence of AEs and SAEs. Treatment group 1-7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase.
Time frame: Visit 4 (Day 42)
Type and incidence of AEs and SAEs. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Time frame: Day 90
Type and incidence of AEs and SAEs of special intrerest. Treatment group 7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Time frame: Day 111
Type and incidence of AEs and SAEs of special intrerest. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Time frame: Day 180
Type and incidence of AEs and SAEs of special intrerest. Treatment group 7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the safety follow-up phase.
Time frame: Day 201
Type and incidence of AEs and SAEs of special intrerest. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Time frame: Visit 2 (Day 0)
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.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Time frame: Visit 2 (Day 0)
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.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Time frame: Visit 2 (Day 0)
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.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the treatment visits.
Time frame: Visit 3 (Day 21)
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.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Frequency of clinically significant changes in ECG. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Frequency of clinically significant changes in ECG. Treatment group 7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Frequency of clinically significant changes in vital signs. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Frequency of clinically significant changes in vital signs. Treatment group 7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Frequency of clinically significant changes in physical examination findings. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Frequency of clinically significant changes in physical examination findings. Treatment group 7.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 4 (Day 42)
Frequency of clinically significant changes in laboratory variables. Treatment group 1-6.
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, from baseline to last clinic visit.
Time frame: Visit 1 (Day -42 to -1) to Visit 3 (Day 21)
Frequency of clinically significant changes in laboratory variables. Treatment group 7.
12 secondary outcomes
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 4 (Day 42)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 2 (Day 0)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 3 (Day 21)
Evaluation of the immune response to Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens.
Time frame: Visit 4 (Day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Rein Hedin, MD principal investigator
CTC Clinical Trial Consultants AB
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immunose™ FLU 1%, Immunose™ FLU 2%, 200 μl and Immunose™ FLU 2%, 300 μl in people with Influenza, run by Eurocine Vaccines AB at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigens, during the clinical phase. (time frame: Visit 2 (Day 0)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.