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Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998996
Recruitment Status : Completed
First Posted : December 21, 2016
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Eurocine Vaccines AB

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: 15 µg HA/strain and 1% Endocine™ Biological: 15 µg HA/strain and 2% Endocine™ Biological: 15 µg HA/strain Biological: intramuscular comparator Biological: intranasal comparator Biological: Placebo, Saline Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Immunose™ FLU 1%,
15 µg haemagglutinin(HA)/strain and 1% Endocine™
 Biological: 15 µg HA/strain and 1% Endocine™
intranasal administration
Experimental: Immunose™ FLU 2%,
15 µg HA/strain and 2% Endocine™
 Biological: 15 µg HA/strain and 2% Endocine™
intranasal administration
Experimental: Influenza antigen,
15 µg HA/strain
 Biological: 15 µg HA/strain
intranasal administration
Placebo Comparator: Saline (NaCl),
Placebo
 Biological: Placebo, Saline
intranasal administration
Active Comparator: i.m. comparator,
15 µg HA/strain
 Biological: intramuscular comparator
intramuscular administration
Active Comparator: i.n. comparator Biological: intranasal comparator
intranasal administration


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998996


Locations
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Sweden
Site 2
Linkoping, Sweden
Site 1
Uppsala, Sweden
Sponsors and Collaborators
Eurocine Vaccines AB
Investigators
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Principal Investigator: Cornelia Lif-Tiberg, MD CTC
  Study Documents (Full-Text)

Documents provided by Eurocine Vaccines AB:
Study Protocol and Statistical Analysis Plan  [PDF] June 30, 2016

More Information
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Responsible Party: Eurocine Vaccines AB
ClinicalTrials.gov Identifier: NCT02998996    
Other Study ID Numbers: EURO 15-11
First Posted: December 21, 2016    Key Record Dates
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Diseases
Endocine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs