Influenza, HumanPhase 1/2NCT02998996
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
A Phase 1/2 study testing 15 µg HA/strain and 1% Endocine™, 15 µg HA/strain and 2% Endocine™ and 15 µg HA/strain in people with Influenza, Human, run by Eurocine Vaccines AB at 2 sites in Sweden.
Trial summary
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- 15 µg HA/strain and 1% Endocine™, 15 µg HA/strain and 2% Endocine™ and 15 µg HA/strain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2016to 1 Jun 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to any study related procedures.
- Male or female 18-39 years of age (both inclusive) at screening
- Subjects who the Investigator believes will comply with the requirements of the protocol.
- BMI: 18.0 and 30.0 kg/m2 (inclusive).
- 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.
- From the signing of the informed consent until 2 months after the last vaccination (Visit 3 for group 1 to 4 and Visit 2 for group 5 and 6) female subjects 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 2015/2016 season.
- Use of any investigational drug product within 3 months before screening or planned use during the study period, including the safety follow-up.
- Administration of an influenza vaccine during the 6 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.
- Any contra-indication to intramuscular administration of the influenza vaccine AdimFlu-S according to its prescribing information.
- Any contra-indication to administration of the influenza vaccine Fluenz Tetra according to its summary of product characteristics (SmPC).
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- 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 and neomycin sulphate).
- 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.
- History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Received blood, blood products and/or plasma derivatives or any administration of immunoglobulin preparation within the three 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 and HIV.
- Pregnant or lactating female or intent to become pregnant during the clinic phase (up until and including Visit 4 for group 1 to 4 and Visit 3 for group 5 and 6) 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
2 sites in 1 country.
About this study
Official title: A Phase I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.
- Conditions
- Influenza, Human
- Being tested
- 15 µg HA/strain and 1% Endocine™, 15 µg HA/strain and 2% Endocine™, 15 µg HA/strain, intramuscular comparator, intranasal comparator
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 µg HA/strain and 1% Endocine™Biological
intranasal administration
15 µg HA/strain and 2% Endocine™Biological
intranasal administration
15 µg HA/strainBiological
intranasal administration
intramuscular comparatorBiological
intramuscular administration
intranasal comparatorBiological
intranasal administration
Placebo, SalineBiological
intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Immunose™ FLU 1%, | Experimental | 15 µg haemagglutinin(HA)/strain and 1% Endocine™ Receives: Biological: 15 µg HA/strain and 1% Endocine™ |
| Immunose™ FLU 2%, | Experimental | 15 µg HA/strain and 2% Endocine™ Receives: Biological: 15 µg HA/strain and 2% Endocine™ |
| Influenza antigen, | Experimental | 15 µg HA/strain Receives: Biological: 15 µg HA/strain |
| Saline (NaCl), | Placebo comparator | Placebo Receives: Biological: Placebo, Saline |
| i.m. comparator, | Active comparator | 15 µg HA/strain Receives: Biological: intramuscular comparator |
| i.n. comparator | Active comparator | Not described Receives: Biological: intranasal comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tolerability - First Dose
Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
Measured: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).
Local Tolerability - Second Dose (Group 1-4 Only)
Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
Measured: Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza, HumanStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurocine Vaccines AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelia Lif-Tiberg, MD, Principal investigator, CTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998996
- Sponsor's protocol ID
- EURO 15-11
- Status last verified
- Oct 2018
- First submitted
- 10 Nov 2016
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
- ClinicalTrials.gov ID
- NCT02998996
- Acronym / sponsor ID
- EURO 15-11
- Conditions
- Influenza, Human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Eurocine Vaccines ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 21 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Immunose™ FLU 1%, | Experimental | Biological: 15 µg HA/strain and 1% Endocine™15 µg haemagglutinin(HA)/strain and 1% Endocine™ |
| Immunose™ FLU 2%, | Experimental | Biological: 15 µg HA/strain and 2% Endocine™15 µg HA/strain and 2% Endocine™ |
| Influenza antigen, | Experimental | Biological: 15 µg HA/strain15 µg HA/strain |
| Saline (NaCl), | Placebo comparator | Biological: Placebo, SalinePlacebo |
| i.m. comparator, | Active comparator | Biological: intramuscular comparator15 µg HA/strain |
| i.n. comparator | Active comparator | Biological: intranasal comparator |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent prior to any study related procedures.
- Male or female 18-39 years of age (both inclusive) at screening
- Subjects who the Investigator believes will comply with the requirements of the protocol.
- BMI: 18.0 and 30.0 kg/m2 (inclusive).
- 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.
Key exclusion criteria (24 listed)
- Diagnosis of laboratory-confirmed influenza in the 2015/2016 season.
- Use of any investigational drug product within 3 months before screening or planned use during the study period, including the safety follow-up.
- Administration of an influenza vaccine during the 6 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.
- Any contra-indication to intramuscular administration of the influenza vaccine AdimFlu-S according to its prescribing information.
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 |
|---|---|---|
| 15 µg HA/strain and 1% Endocine™intranasal administration | Biological | Immunose™ FLU 1%, |
| 15 µg HA/strain and 2% Endocine™intranasal administration | Biological | Immunose™ FLU 2%, |
| 15 µg HA/strainintranasal administration | Biological | Influenza antigen, |
| intramuscular comparatorintramuscular administration | Biological | i.m. comparator, |
| intranasal comparatorintranasal administration | Biological | i.n. comparator |
| Placebo, Salineintranasal administration | Biological | Saline (NaCl), |
Primary outcome
Local Tolerability - First Dose
Time frame: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).
Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
Local Tolerability - Second Dose (Group 1-4 Only)
Time frame: Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).
Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Cornelia Lif-Tiberg, MD principal investigator
CTC
2 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 15 µg HA/strain and 1% Endocine™, 15 µg HA/strain and 2% Endocine™ and 15 µg HA/strain in people with Influenza, Human, run by Eurocine Vaccines AB at 2 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 6 inclusion and 24 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Local Tolerability - First Dose (time frame: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).). The study lists 2 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 21 Feb 2019.