InfluenzaPhase 4NCT01404182
Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons
A Phase 4 study testing Vaccination with Fluval AB influenza vaccine in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 2 sites in Hungary.
Trial summary
The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccination with Fluval AB influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesHungary
- Study dates
- Jul 2011to Aug 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 60 years, elderly persons aged over 60 years, both sexes, mentally competent
- Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study
- Female volunteers aged 18-60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
- Capability of participants to understand and comply with planned study procedures
- Participants aged above 18 years provide written informed consent prior to initiation of study procedures
- Absence of existence of any exclusion criteria.
Who cannot join
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine
- History of Guillain-Barré syndrome
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
- Immunosuppressive therapy within the past 36 months
Show all 18Show fewer
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids
- Receipt of immunostimulants,
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within the past 3 months
- Suspected or HIV, HBV or HCV infection
- Acute disease and/or axillary temperature ≥37oC within the past 3 days
- Vaccine therapy within the past 4 weeks
- Influenza vaccination (any kind) within the past 6 months
- Experimental drug therapy within the past 4 weeks
- Concomitant participation in another clinical study
- Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study
- Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer
- Alcohol or drug abuse of the participant.
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Family Doctor's Office
Pilisvörösvár, Pest County, H-2097
Fourmed Gyogyhaz Kft.
Veszprém, Veszprém megye, H-8200
About this study
Official title: Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons
The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.
Read the detailed description
Immunogenicity Objective:
To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Safety and Tolerability Objectives:
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).
- Conditions
- Influenza
- Being tested
- Vaccination with Fluval AB influenza vaccine
- Keywords
- seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans
- Medical subject headings
- Influenza, Human, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with Fluval AB influenza vaccineBiological
Also called Influenza, Seasonal vaccine, Vaccination, Prevention
Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination | Experimental | Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant. Receives: Biological: Vaccination with Fluval AB influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post vaccination HI antibody titer
Measured: 21-28 days following vaccination
Secondary outcomes (1)
Incidence of adverse reactions
Measured: 21-28 days following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferenc Tamás, MD, Principal investigator, Family Doctor's Office PilisvorosvarLászló Sinka, MD, Principal investigator, Fourmed Gyogyhaz Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404182
- Sponsor's protocol ID
- FluvalAB-H-YL2011
- Other IDs
- 2011-002158-30
- Status last verified
- May 2012
- First submitted
- 26 Jul 2011
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons
- ClinicalTrials.gov ID
- NCT01404182
- Acronym / sponsor ID
- FluvalAB-H-YL2011
- Conditions
- Influenza
- Keywords
- seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Jul 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 purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.
Detailed description
Immunogenicity Objective:
To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Safety and Tolerability Objectives:
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination | Experimental | Biological: Vaccination with Fluval AB influenza vaccineVaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 60 years, elderly persons aged over 60 years, both sexes, mentally competent
- Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study
- Female volunteers aged 18-60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
- Capability of participants to understand and comply with planned study procedures
- Participants aged above 18 years provide written informed consent prior to initiation of study procedures
Key exclusion criteria (18 listed)
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine
- History of Guillain-Barré syndrome
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
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 |
|---|---|---|
| Vaccination with Fluval AB influenza vaccineAlso: Influenza, Seasonal vaccine, Vaccination, PreventionVaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant. | Biological | Influenza vaccination |
Primary outcome
Post vaccination HI antibody titer
Time frame: 21-28 days following vaccination
1 secondary outcome
Incidence of adverse reactions
Time frame: 21-28 days following vaccination
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 21 May 2012.
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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.
Ferenc Tamás, MD principal investigator
Family Doctor's Office Pilisvorosvar
László Sinka, MD principal investigator
Fourmed Gyogyhaz Kft.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccination with Fluval AB influenza vaccine in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 2 sites 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 6 inclusion and 18 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Post vaccination HI antibody titer (time frame: 21-28 days following vaccination). 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 21 May 2012.