InfluenzaPhase 1NCT01444482
Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers
A Phase 1 study testing Matrix M and Seasonal influenza vaccine in people with Influenza, run by Isconova AB at 1 site in Hungary.
Trial summary
The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Matrix M and Seasonal influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteHungary
- Study dates
- May 2011to Nov 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Are aged 18 to 50 years for the young adult part of the study
- Are aged 65 to 75 years for main study
- Have signed a voluntary written informed consent. Volunteers should be cooperative, willing and able to participate and adhere to the Protocol requirements
- Have minimum normal standard physical performance status
Who cannot join
- Volunteer has received seasonal Influenza vaccine of same antigenic composition within 6 months prior to enrolment
- Volunteer having vaccine specific HI titres ≥ 40
- Volunteer is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc
- Volunteers who have primary or secondary immunodeficiencies (e.g. Human Immunodeficiency Virus [HIV])
- Volunteers who have an autoimmune disease
- Volunteer is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month of Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), are permitted
Show all 17Show fewer
- Volunteer has a concurrent severe or uncontrolled underlying medical disease unrelated but that is likely to compromise volunteer safety and affect the outcome of the study
- Volunteer has a neurotoxicity (Grade ≥2)
- Volunteer has diarrhoea (Grade ≥2)
- Volunteer has received other vaccines, within 1 month prior to enrolment
- Volunteer has a history of any severe or life-threatening hypersensitivity reaction
- Volunteer has an unstable systemic disease (including active infection, uncontrolled hypertension [> 160/100], unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease)
- Volunteer has recent history (within 6 months) of chronic alcohol or drug abuse of which may compromise the patient's safety or ability to participate in study activities
- Volunteer has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions
- Volunteer is currently enrolled in an investigational device or drug trial, or < 1 month since completing an investigational device or drug trial
- Female volunteers who are pregnant or lactating (only applicable for Pre-Study)
- Volunteer has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single Blinded Randomised Exploratory Trial in Elderly Volunteers to Assess and Compare Safety and Immunogenicity of Adjuvanted Seasonal Influenza Vaccine (Investigational Vaccine) to Standard Seasonal Influenza Vaccine.
The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response.
Vaccination will start in 22 healthy adults receiving the investigational vaccine. Vaccination of elderly will be initiated only after demonstration of safety in adults. 88 healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine alone and 44 will receive the investigational vaccine. Vaccines will be administrated intramuscularly in the upper arm. One dose will be administered to each volunteer included in the study. Blood samples for basic immunological assessments of cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150.
The investigational vaccine is equal to one standard human dose of a commercial seasonal influenza vaccine to which 50 µg of adjuvant Matrix M has been added.
- Conditions
- Influenza
- Being tested
- Matrix M, Seasonal influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix MBiological
1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0.
Seasonal influenza vaccineBiological
1 human dose of seasonal influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| Matrix M adjuvanted influenza vaccine | Experimental | 1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M Receives: Biological: Matrix M |
| Seasonal influenza vaccine | Active comparator | 1 human dose of seasonal influenza vaccine Receives: Biological: Seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M
Measured: 1 - 3 months
Secondary outcomes (2)
Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M
Measured: 1 - 7 months
Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M
Measured: 1 - 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isconova AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444482
- Sponsor's protocol ID
- ISC-Influenza-001
- Status last verified
- Sep 2011
- First submitted
- 19 Aug 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Blinded Randomised Exploratory Trial in Elderly Volunteers to Assess and Compare Safety and Immunogenicity of Adjuvanted Seasonal Influenza Vaccine (Investigational Vaccine) to Standard Seasonal Influenza Vaccine.
- ClinicalTrials.gov ID
- NCT01444482
- Acronym / sponsor ID
- ISC-Influenza-001
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Isconova ABIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2011 (estimated)
- First posted
- 30 Sep 2011 (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.
The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response.
Vaccination will start in 22 healthy adults receiving the investigational vaccine. Vaccination of elderly will be initiated only after demonstration of safety in adults. 88 healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine alone and 44 will receive the investigational vaccine. Vaccines will be administrated intramuscularly in the upper arm. One dose will be administered to each volunteer included in the study. Blood samples for basic immunological assessments of cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150.
The investigational vaccine is equal to one standard human dose of a commercial seasonal influenza vaccine to which 50 µg of adjuvant Matrix M has been added.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matrix M adjuvanted influenza vaccine | Experimental | Biological: Matrix M1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M |
| Seasonal influenza vaccine | Active comparator | Biological: Seasonal influenza vaccine1 human dose of seasonal influenza vaccine |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Are aged 18 to 50 years for the young adult part of the study
- Are aged 65 to 75 years for main study
- Have signed a voluntary written informed consent. Volunteers should be cooperative, willing and able to participate and adhere to the Protocol requirements
- Have minimum normal standard physical performance status
Key exclusion criteria (17 listed)
- Volunteer has received seasonal Influenza vaccine of same antigenic composition within 6 months prior to enrolment
- Volunteer having vaccine specific HI titres ≥ 40
- Volunteer is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc
- Volunteers who have primary or secondary immunodeficiencies (e.g. Human Immunodeficiency Virus [HIV])
- Volunteers who have an autoimmune disease
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 |
|---|---|---|
| Matrix M1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0. | Biological | Matrix M adjuvanted influenza vaccine |
| Seasonal influenza vaccine1 human dose of seasonal influenza vaccine | Biological | Seasonal influenza vaccine |
Primary outcome
Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M
Time frame: 1 - 3 months
2 secondary outcomes
Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M
Time frame: 1 - 7 months
Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M
Time frame: 1 - 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Matrix M and Seasonal influenza vaccine in people with Influenza, run by Isconova AB at 1 site in Hungary.
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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M (time frame: 1 - 3 months). 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 30 Sep 2011.