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

NCT02998996 | Completed Phase 1 Results

• 1 other identifier: EURO 15-11
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).

Study Arms (6)

Immunose™ FLU 1%,

EXPERIMENTAL

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

Biological: 15 µg HA/strain and 1% Endocine™

Immunose™ FLU 2%,

EXPERIMENTAL

15 µg HA/strain and 2% Endocine™

Biological: 15 µg HA/strain and 2% Endocine™

Influenza antigen,

EXPERIMENTAL

15 µg HA/strain

Biological: 15 µg HA/strain

Saline (NaCl),

PLACEBO COMPARATOR

Placebo

Biological: Placebo, Saline

i.m. comparator,

ACTIVE COMPARATOR

15 µg HA/strain

Biological: intramuscular comparator

i.n. comparator

ACTIVE COMPARATOR

Biological: intranasal comparator

Interventions

15 µg HA/strain and 1% Endocine™ BIOLOGICAL

intranasal administration

Immunose™ FLU 1%,

15 µg HA/strain and 2% Endocine™ BIOLOGICAL

intranasal administration

Immunose™ FLU 2%,

15 µg HA/strain BIOLOGICAL

intranasal administration

Influenza antigen,

intramuscular comparator BIOLOGICAL

intramuscular administration

i.m. comparator,

intranasal comparator BIOLOGICAL

intranasal administration

i.n. comparator

Placebo, Saline BIOLOGICAL

intranasal administration

Saline (NaCl),

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurocine Vaccines AB: lead

Study Sites (2)

Site 2

Linköping, Sweden

Location

Site 1

Uppsala, Sweden

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Endocine; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Anna-Karin Maltais
• Organization: Eurocine Vaccines AB

annakarin.maltais@eurocine-vaccines.com

+46 76 233 81 62

Study Officials

• Cornelia Lif-Tiberg, MD

  CTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: December 21, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)