Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
NCT ID: NCT03437304
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
298 participants
INTERVENTIONAL
2018-02-09
2018-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immunose™ FLU 1%
Immunose™ FLU 1%. QIV, 30 μg HA/strain and 1% Endocine™ 200 μl for intranasal administration, 2 dosing occasions.
Immunose™ FLU 1%
Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 200 μl
Immunose™ FLU 2%. QIV, 30 μg HA/strain and 2% Endocine™, 200 μl for intranasal administration, 2 dosing occasions.
Immunose™ FLU 2%, 200 μl
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 300 μl
Immunose™ FLU 2%, 300 μl. QIV, 30 μg HA/strain and 2% Endocine™, 300 μl for intranasal administration, 2 dosing occasions.
Immunose™ FLU 2%, 300 μl
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2
Influenza antigen
Influenza antigen. QIV, 30 μg HA/strain, 200 μl for intranasal administrations, 2 dosing occasions.
Influenza antigen
Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2
Placebo
Placebo. Saline (NaCl), 200 μl for intranasal administration, 2 dosing occasions.
Placebo
NaCl dosing volume 200 μl, intranasal administration x 2
i.m comparator and Immunose™ FLU 2%
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.
Immunose™ FLU 2%, 200 μl
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
i.m comparator
Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
i.m comparator
i.m comparator. QIV 15 μg HA/strain, 500 µl for a single intramuscular administration.
i.m comparator
Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immunose™ FLU 1%
Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 200 μl
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
Immunose™ FLU 2%, 300 μl
Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2
Influenza antigen
Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2
Placebo
NaCl dosing volume 200 μl, intranasal administration x 2
i.m comparator
Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female 50 to75 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. 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.
Exclusion Criteria
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 comparator influenza vaccine 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.
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eurocine Vaccines AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erik Rein Hedin, MD
Role: PRINCIPAL_INVESTIGATOR
CTC Clinical Trial Consultants AB
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 5
Borås, , Sweden
Site 4
Helsingborg, , Sweden
Site 2
Linköping, , Sweden
Site 3
Malmo, , Sweden
Site 1
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EURO 17-09
Identifier Type: -
Identifier Source: org_study_id