- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02998996
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
October 8, 2018 updated by: Eurocine Vaccines AB
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Linkoping, Sweden
- Site 2
-
Uppsala, Sweden
- Site 1
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunose™ FLU 1%,
15 µg haemagglutinin(HA)/strain and 1% Endocine™
|
intranasal administration
|
Experimental: Immunose™ FLU 2%,
15 µg HA/strain and 2% Endocine™
|
intranasal administration
|
Experimental: Influenza antigen,
15 µg HA/strain
|
intranasal administration
|
Placebo Comparator: Saline (NaCl),
Placebo
|
intranasal administration
|
Active Comparator: i.m. comparator,
15 µg HA/strain
|
intramuscular administration
|
Active Comparator: i.n. comparator
|
intranasal administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-dose, and 15 and 120 min after study drug administration (Visit 2).
|
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.
|
Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cornelia Lif-Tiberg, MD, CTC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
November 10, 2016
First Submitted That Met QC Criteria
December 16, 2016
First Posted (Estimate)
December 21, 2016
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EURO 15-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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