Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults
Primary Purpose
Influenza A
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FP-01.1 + Placebo
FP-01.1 + TIV
FP-01.1-Adjuvant + Placebo
FP-01.1-Adjuvant + TIV
Adjuvant + TIV
Placebo + TIV
FP-01.1
FP-01.1-Adjuvant
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza A focused on measuring Influenza A
Eligibility Criteria
Inclusion Criteria:
- Age 65 to 74 years inclusive at the time of consent
- Female subjects will be post-menopausal (no menses for at least 2 years) and therefore of non-child bearing potential
- Male subjects willing to comply with the applicable contraceptive requirements of the protocol, e.g. must agree to refrain from fathering a child until after the safety follow up visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had a hysterectomy or bilateral oophorectomy. If a male subject's partner is of child bearing potential, male subjects must agree to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner, until after the safety follow up visit.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology & biochemistry) as assessed by the Investigator in relation to the age of the patient.
- An understanding, ability and willingness to fully comply with study procedures and restrictions
- Ability to provide written, personally signed and dated informed consent to participate in the study.
- The subject has a BMI < 35.
Exclusion Criteria:
- As a result of the medical screening process, the Principal Investigator or Co- Investigator considers the subject unfit for the study.
- Women of child-bearing potential
- Clinically significant , uncontrolled, current, chronic or recurrent disease, as deemed by the Investigator, (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the IMP or could affect clinical or laboratory assessments.
- Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
- Subjects with a history of allergies or allergic conditions including anaphylactic reactions, asthmatics, hay fever, allergy to egg products and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co- Investigator will affect their participation in the study.
- Subjects receiving medications that affect the immune system including systemic steroids at a dose greater than 5mg and patients on chronic medications where the dose has not been stable for at least 3 months. Inhaled or topical steroids will be allowed.
- Known or suspected intolerance or hypersensitivity to the IMP, or closely related compounds or any of the stated ingredients.
- Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
- A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
- Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site.
- Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
- Use of another investigational medicinal product within 90 days prior to receiving the first dose of IMP or intention to enrol in another clinical study throughout the entire study including the follow up period.
- Subject with suspected recent (≤6 months) experience of influenza-like illness (fever [>37.8ºC] and cough and/or sore throat > 2 days- in the absence of a known cause other than influenza)
- Subjects who have received a flu vaccine in the last 6 months
- Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms (ECGs)
- In addition, for each subject, a completed medical history questionnaire will be taken as part of the consented study procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Arm Description
Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1
Day 1: FP-01.1 + TIV ; Day 29: FP-01.1
Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant
Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant
Day 1: Adjuvant + TIV ; Day 29: Placebo
Day 1: Placebo + TIV ; Day 29: Placebo
Outcomes
Primary Outcome Measures
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
To assess and compare the immunogenicity response between groups
The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Number and proportion of subjects with abnormal vital signs/ECG assessments
Secondary Outcome Measures
Exploratory immunogenicity tests on samples obtained from subjects
To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
Full Information
NCT ID
NCT01701752
First Posted
October 3, 2012
Last Updated
July 26, 2013
Sponsor
Immune Targeting Systems Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01701752
Brief Title
Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults
Official Title
A Randomised, Double Blind, Double Observer Study to Assess Repeated Administration of a Single Dose of an Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Dose of a Trivalent Inactivated Influenza Virus Vaccine in Subjects 65 to 74 Years of Age.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Targeting Systems Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age, subjects that are more representative of the target population. Both formulations will be administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV) vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A
Keywords
Influenza A
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Day 1: FP-01.1 + TIV ; Day 29: FP-01.1
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant
Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
Day 1: Adjuvant + TIV ; Day 29: Placebo
Arm Title
Group 6
Arm Type
Active Comparator
Arm Description
Day 1: Placebo + TIV ; Day 29: Placebo
Intervention Type
Biological
Intervention Name(s)
FP-01.1 + Placebo
Intervention Type
Biological
Intervention Name(s)
FP-01.1 + TIV
Intervention Type
Biological
Intervention Name(s)
FP-01.1-Adjuvant + Placebo
Intervention Type
Biological
Intervention Name(s)
FP-01.1-Adjuvant + TIV
Intervention Type
Biological
Intervention Name(s)
Adjuvant + TIV
Intervention Type
Biological
Intervention Name(s)
Placebo + TIV
Intervention Type
Biological
Intervention Name(s)
FP-01.1
Intervention Type
Biological
Intervention Name(s)
FP-01.1-Adjuvant
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Time Frame
Day 1- 209
Title
To assess and compare the immunogenicity response between groups
Description
The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
Time Frame
Day 1- 209
Title
Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
Time Frame
Day 1- 209
Title
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Time Frame
Day 1- 209
Title
Number and proportion of subjects with abnormal vital signs/ECG assessments
Time Frame
Day 1 - 209
Secondary Outcome Measure Information:
Title
Exploratory immunogenicity tests on samples obtained from subjects
Time Frame
Day 1 -209
Title
To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
Time Frame
Day 1-209
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 65 to 74 years inclusive at the time of consent
Female subjects will be post-menopausal (no menses for at least 2 years) and therefore of non-child bearing potential
Male subjects willing to comply with the applicable contraceptive requirements of the protocol, e.g. must agree to refrain from fathering a child until after the safety follow up visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had a hysterectomy or bilateral oophorectomy. If a male subject's partner is of child bearing potential, male subjects must agree to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner, until after the safety follow up visit.
Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology & biochemistry) as assessed by the Investigator in relation to the age of the patient.
An understanding, ability and willingness to fully comply with study procedures and restrictions
Ability to provide written, personally signed and dated informed consent to participate in the study.
The subject has a BMI < 35.
Exclusion Criteria:
As a result of the medical screening process, the Principal Investigator or Co- Investigator considers the subject unfit for the study.
Women of child-bearing potential
Clinically significant , uncontrolled, current, chronic or recurrent disease, as deemed by the Investigator, (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the IMP or could affect clinical or laboratory assessments.
Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
Subjects with a history of allergies or allergic conditions including anaphylactic reactions, asthmatics, hay fever, allergy to egg products and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co- Investigator will affect their participation in the study.
Subjects receiving medications that affect the immune system including systemic steroids at a dose greater than 5mg and patients on chronic medications where the dose has not been stable for at least 3 months. Inhaled or topical steroids will be allowed.
Known or suspected intolerance or hypersensitivity to the IMP, or closely related compounds or any of the stated ingredients.
Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site.
Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
Use of another investigational medicinal product within 90 days prior to receiving the first dose of IMP or intention to enrol in another clinical study throughout the entire study including the follow up period.
Subject with suspected recent (≤6 months) experience of influenza-like illness (fever [>37.8ºC] and cough and/or sore throat > 2 days- in the absence of a known cause other than influenza)
Subjects who have received a flu vaccine in the last 6 months
Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms (ECGs)
In addition, for each subject, a completed medical history questionnaire will be taken as part of the consented study procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Leroux-Roels, Professor
Organizational Affiliation
Centre for Vaccinology, Ghent University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults
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