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

NCT ID: NCT02998996

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-01

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.

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Immunose™ FLU 1%,

15 µg haemagglutinin(HA)/strain and 1% Endocine™

Group Type: EXPERIMENTAL

15 µg HA/strain and 1% Endocine™

Intervention Type: BIOLOGICAL

intranasal administration

Immunose™ FLU 2%,

15 µg HA/strain and 2% Endocine™

Group Type: EXPERIMENTAL

15 µg HA/strain and 2% Endocine™

Intervention Type: BIOLOGICAL

intranasal administration

Influenza antigen,

15 µg HA/strain

Group Type: EXPERIMENTAL

15 µg HA/strain

Intervention Type: BIOLOGICAL

intranasal administration

Saline (NaCl),

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo, Saline

Intervention Type: BIOLOGICAL

intranasal administration

i.m. comparator,

15 µg HA/strain

Group Type: ACTIVE_COMPARATOR

intramuscular comparator

Intervention Type: BIOLOGICAL

intramuscular administration

i.n. comparator

Group Type: ACTIVE_COMPARATOR

intranasal comparator

Intervention Type: BIOLOGICAL

intranasal administration

Interventions

15 µg HA/strain and 1% Endocine™

intranasal administration

Intervention Type: BIOLOGICAL

15 µg HA/strain and 2% Endocine™

intranasal administration

Intervention Type: BIOLOGICAL

15 µg HA/strain

intranasal administration

Intervention Type: BIOLOGICAL

intramuscular comparator

intramuscular administration

Intervention Type: BIOLOGICAL

intranasal comparator

intranasal administration

Intervention Type: BIOLOGICAL

Placebo, Saline

intranasal administration

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eurocine Vaccines AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia Lif-Tiberg, MD

Role: PRINCIPAL_INVESTIGATOR

CTC

Locations

Site 2

Linköping, , Sweden

Site 1

Uppsala, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EURO 15-11

Identifier Type: -

Identifier Source: org_study_id