Influenza APhase 1NCT01701752
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
A Phase 1 study testing FP-01.1 + TIV, FP-01.1-Adjuvant + TIV and Adjuvant + TIV in people with Influenza A, run by Immune Targeting Systems Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- FP-01.1 + TIV, FP-01.1-Adjuvant + TIV and Adjuvant + TIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 74 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
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.
- Conditions
- Influenza A
- Being tested
- FP-01.1 + Placebo, FP-01.1 + TIV, FP-01.1-Adjuvant + Placebo, FP-01.1-Adjuvant + TIV, Adjuvant + TIV
- Keywords
- Influenza A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP-01.1 + PlaceboBiological
FP-01.1 + TIVBiological
FP-01.1-Adjuvant + PlaceboBiological
FP-01.1-Adjuvant + TIVBiological
Adjuvant + TIVBiological
Placebo + TIVBiological
FP-01.1Biological
FP-01.1-AdjuvantBiological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1 Receives: Biological: FP-01.1 + Placebo; Biological: FP-01.1 |
| Group 2 | Active comparator | Day 1: FP-01.1 + TIV ; Day 29: FP-01.1 Receives: Biological: FP-01.1 + TIV; Biological: FP-01.1 |
| Group 3 | Active comparator | Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant Receives: Biological: FP-01.1-Adjuvant + Placebo; Biological: FP-01.1-Adjuvant |
| Group 4 | Active comparator | Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant Receives: Biological: FP-01.1-Adjuvant + TIV; Biological: FP-01.1-Adjuvant |
| Group 5 | Active comparator | Day 1: Adjuvant + TIV ; Day 29: Placebo Receives: Biological: Adjuvant + TIV; Other: Placebo |
| Group 6 | Active comparator | Day 1: Placebo + TIV ; Day 29: Placebo Receives: Biological: Placebo + TIV; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Measured: Day 1- 209
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
Measured: Day 1- 209
Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
Measured: Day 1- 209
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Measured: Day 1- 209
Number and proportion of subjects with abnormal vital signs/ECG assessments
Measured: Day 1 - 209
Secondary outcomes (2)
Exploratory immunogenicity tests on samples obtained from subjects
Measured: Day 1 -209
To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
Measured: Day 1-209
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune Targeting Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert Leroux-Roels, Professor, Principal investigator, Centre for Vaccinology, Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701752
- Sponsor's protocol ID
- FP-01.1_CS_03
- Status last verified
- Jul 2013
- First submitted
- 3 Oct 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01701752
- Acronym / sponsor ID
- FP-01.1_CS_03
- Conditions
- Influenza A
- Keywords
- Influenza A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Immune Targeting Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: FP-01.1 + Placebo, Biological: FP-01.1Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1 |
| Group 2 | Active comparator | Biological: FP-01.1 + TIV, Biological: FP-01.1Day 1: FP-01.1 + TIV ; Day 29: FP-01.1 |
| Group 3 | Active comparator | Biological: FP-01.1-Adjuvant + Placebo, Biological: FP-01.1-AdjuvantDay 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant |
| Group 4 | Active comparator | Biological: FP-01.1-Adjuvant + TIV, Biological: FP-01.1-AdjuvantDay 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant |
| Group 5 | Active comparator | Biological: Adjuvant + TIV, Other: PlaceboDay 1: Adjuvant + TIV ; Day 29: Placebo |
| Group 6 | Active comparator | Biological: Placebo + TIV, Other: PlaceboDay 1: Placebo + TIV ; Day 29: Placebo |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP-01.1 + Placebo | Biological | Group 1 |
| FP-01.1 + TIV | Biological | Group 2 |
| FP-01.1-Adjuvant + Placebo | Biological | Group 3 |
| FP-01.1-Adjuvant + TIV | Biological | Group 4 |
| Adjuvant + TIV | Biological | Group 5 |
| Placebo + TIV | Biological | Group 6 |
| FP-01.1 | Biological | Group 1, Group 2 |
| FP-01.1-Adjuvant | Biological | Group 3, Group 4 |
| Placebo | Other | Group 5, Group 6 |
Primary outcome
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Time frame: Day 1- 209
To assess and compare the immunogenicity response between groups
Time frame: Day 1- 209
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)
Time frame: Day 1- 209
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Time frame: Day 1- 209
Number and proportion of subjects with abnormal vital signs/ECG assessments
Time frame: Day 1 - 209
2 secondary outcomes
Exploratory immunogenicity tests on samples obtained from subjects
Time frame: Day 1 -209
To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
Time frame: Day 1-209
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Leroux-Roels, Professor principal investigator
Centre for Vaccinology, Ghent University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FP-01.1 + TIV, FP-01.1-Adjuvant + TIV and Adjuvant + TIV in people with Influenza A, run by Immune Targeting Systems Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions (time frame: Day 1- 209). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.