InfluenzaPhase 4NCT01649713
Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season
A Phase 4 study testing Fluval AB vaccination in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 3 sites in Hungary.
Trial summary
This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection… 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?
- Fluval AB vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesHungary
- Study dates
- Aug 2012to Sep 2012
- 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
- Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from 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 18-59 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 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, vancomycin 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 36 months prior to vaccination;
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- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants;
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
- Suspected or known HIV, HBV or HCV infection;
- Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
- Vaccine therapy within 4 weeks prior to vaccination;
- Influenza vaccination (any kind) within 6 months prior to vaccination;
- Experimental drug therapy within 4 weeks prior to vaccination;
- 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
3 sites in 1 country.
Hungary3 sites
District Doctor's Office
Budapest, H-1083
District Doctor's Office
Pilisvörösvar, H-2085
District Doctor's Office
Szentendre, H-2000
About this study
Official title: Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 ugHA/Strain/0.5mL) in Adult and Elderly Subjects
This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Read the detailed description
For the 2011-2012 vaccination season the following influenza virus strains were recommended to be included in the influenza vaccines:
- A/California/7/2009(H1N1)-like virus,
- A/Perth/16/2009(H3N2)-like virus,
- B/Brisbane/60/2008-like virus.
For the 2012-2013 season the following strains were recommended (Amended EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2012/2013, EMA/CHMP/BWP/140597/2012):
- A/California/7/2009(H1N1)-like virus,
- A/Victoria/361/2011(H3N2)-like virus,
- B/Wisconsin/1/2010-like virus.
Since the A/H3N2 and the B virus strains were changed, a yearly licence clinical study have to be performed.
- Conditions
- Influenza
- Being tested
- Fluval AB vaccination
- Keywords
- Fluval AB, influenza, vaccine, immunization, infections
- 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.
Fluval AB vaccinationDrug
Vaccination with Fluval AB suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| Fluval AB vaccination | Experimental | In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects will be enrolled into one vaccination group and will be vaccinated by a single injection of Fluval AB suspension for injection. Receives: Drug: Fluval AB vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96
To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96.
Measured: 21-28 days after immunization
Secondary outcomes (1)
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Safety and tolerability will be assessed in comparison to available safety and tolerability data on Fluval AB suspension for injection:
- number and percentage of subjects with at least one local reaction between Day 0 and Day 21-28.
- number and percentage of subjects with at least one systemic reaction between Day 0 and Day 21-28.
- number and percentage of subjects with at least one adverse reaction between Day 0 and Day 21-28.
Measured: From Day 0 until 21-28 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionSep 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brigitta Kozma, MD, Study director, Omninvest Ltd.Ferenc Tamás, MD, Principal investigator, District Doctor's Office, Pilisvörösvar, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649713
- Sponsor's protocol ID
- Fluval AB-H-YL2012
- Other IDs
- 2012-002379-32
- Status last verified
- Oct 2012
- First submitted
- 23 Jul 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 ugHA/Strain/0.5mL) in Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01649713
- Acronym / sponsor ID
- Fluval AB-H-YL2012
- Conditions
- Influenza
- Keywords
- Fluval AB, influenza, vaccine, immunization, infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Jul 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 is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Detailed description
For the 2011-2012 vaccination season the following influenza virus strains were recommended to be included in the influenza vaccines:
- A/California/7/2009(H1N1)-like virus,
- A/Perth/16/2009(H3N2)-like virus,
- B/Brisbane/60/2008-like virus.
For the 2012-2013 season the following strains were recommended (Amended EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2012/2013, EMA/CHMP/BWP/140597/2012):
- A/California/7/2009(H1N1)-like virus,
- A/Victoria/361/2011(H3N2)-like virus,
- B/Wisconsin/1/2010-like virus.
Since the A/H3N2 and the B virus strains were changed, a yearly licence clinical study have to be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluval AB vaccination | Experimental | Drug: Fluval AB vaccinationIn this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects will be enrolled into one vaccination group and will be vaccinated by a single injection of Fluval AB suspension for injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from 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 18-59 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 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, vancomycin 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 |
|---|---|---|
| Fluval AB vaccinationVaccination with Fluval AB suspension for injection | Drug | Fluval AB vaccination |
Primary outcome
Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96
Time frame: 21-28 days after immunization
To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96.
1 secondary outcome
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Time frame: From Day 0 until 21-28 days after immunization
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 12 Oct 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.
Brigitta Kozma, MD study director
Omninvest Ltd.
Ferenc Tamás, MD principal investigator
District Doctor's Office, Pilisvörösvar, Hungary
3 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 Fluval AB vaccination in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 3 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 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96 (time frame: 21-28 days after immunization). 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 12 Oct 2012.