Study to Assess the Safety, Tolerability and Immune Respo... | NCT02998996 | Trialant
NCT02998996
Sponsor
Eurocine Vaccines AB
Status
Completed
Last Update Posted
Feb 21, 2019Actual
Enrollment
162Actual
Phase
Phase 1Phase 2
Conditions
Influenza, Human
Interventions
15 µg HA/strain and 1% Endocine™
15 µg HA/strain and 2% Endocine™
15 µg HA/strain
intramuscular comparator
intranasal comparator
Placebo, Saline
Countries
Sweden
Protocol Section
Identification Module
NCT ID
NCT02998996
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EURO 15-11
Secondary IDs
Not provided
Brief Title
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunoseâ„¢ FLU
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 Immunoseâ„¢ FLU
Acronym
Not provided
Organization
Eurocine Vaccines ABINDUSTRY
Status Module
Record Verification Date
Oct 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2016
Primary Completion Date
Jun 1, 2017Actual
Completion Date
Jun 1, 2017Actual
First Submitted Date
Nov 10, 2016
First Submission Date that Met QC Criteria
Dec 16, 2016
First Posted Date
Dec 21, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 8, 2018
Results First Submitted that Met QC Criteria
Oct 8, 2018
Results First Posted Date
Feb 21, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 8, 2018
Last Update Posted Date
Feb 21, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eurocine Vaccines ABINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of the this study is to evaluate the safety and tolerability of Immunoseâ„¢ FLU based on Endocineâ„¢ and quadrivalent influenza antigen.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
162Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Immunoseâ„¢ FLU 1%,
Experimental
15 µg haemagglutinin(HA)/strain and 1% Endocine™
Biological: 15 µg HA/strain and 1% Endocine™
Immunoseâ„¢ 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
Name
Type
Description
Arm Group Labels
Other Names
15 µg HA/strain and 1% Endocine™
Biological
intranasal administration
Immunoseâ„¢ FLU 1%,
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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).
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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.
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
39 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Cornelia Lif-Tiberg, MD
CTC
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site 2
Linköping
Sweden
Site 1
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Immunoseâ„¢ FLU 1%,
15 µg haemagglutinin(HA)/strain and 1% Endocine™
15 µg HA/strain and 1% Endocine™: intranasal administration
FG001
Immunoseâ„¢ FLU 2%,
15 µg HA/strain and 2% Endocine™
15 µg HA/strain and 2% Endocine™: intranasal administration
Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
Posted
Count of Participants
Participants
Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).
ID
Title
Description
OG000
Immunoseâ„¢ FLU 1%,
15 µg haemagglutinin(HA)/strain and 1% Endocine™
15 µg HA/strain and 1% Endocine™: intranasal administration
OG001
Immunoseâ„¢ FLU 2%,
15 µg HA/strain and 2% Endocine™
15 µg HA/strain and 2% Endocine™: intranasal administration
OG002
Influenza Antigen,
15 µg HA/strain
15 µg HA/strain: intranasal administration
OG003
Saline (NaCl),
Placebo
Placebo, Saline: intranasal administration
Time Frame
From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Immunoseâ„¢ FLU 1%,
15 µg haemagglutinin(HA)/strain and 1% Endocine™
15 µg HA/strain and 1% Endocine™: intranasal administration
0
36
2
36
32
36
EG001
Immunoseâ„¢ FLU 2%,
15 µg HA/strain and 2% Endocine™
15 µg HA/strain and 2% Endocine™: intranasal administration