InfluenzaNCT01459276
A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects
A study testing Vaccination with FAB-6011 and Vaccination with FluvalAB in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 7 sites in Hungary.
Trial summary
The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens 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 FAB-6011 and Vaccination with FluvalAB
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 7 sitesHungary
- Study dates
- Oct 2011to Mar 2012
- Phase
- Interventional
- 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
- male and female adult volunteers aged 18 years or older,
- mentally competent,
- able to understand and comply with all study requirements,
- willing and able to give written informed consent prior to initiation of study procedures,
- in good health (as determined by clinical judgement of the investigator on the basis of medical history 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 subjects aged 18 to 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.
- 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.
- Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
- History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
- History of Guillain-Barré syndrome;
- 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;
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- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants;
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;
- Suspected or known 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 subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
- Alcohol or drug abuse of the subject.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Hungary7 sites
Péter Vajer
Biatorbágy, Pest County, 2051
Family Doctor's Office
Budapest, 1083
Family Doctor's Office
Budapest, 1136
Barna Bőze
Hatvan, Pest County, 3000
Family Doctor's Office
Pilisvörösvár, 2085
Family Doctor's Office
Szentendre, Pest County, 2000
Tibor Hrutka
Vecsés, Pest County, 2220
About this study
Official title: A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6μgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects
The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
- Conditions
- Influenza
- Being tested
- Vaccination with FAB-6011, Vaccination with FluvalAB
- 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 FAB-6011Biological
Also called FAB-6011
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
Vaccination with FluvalABBiological
Also called FluvalAB
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
| Study group | Role | What they receive |
|---|---|---|
| FAB-6011 | Experimental | One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens Receives: Biological: Vaccination with FAB-6011 |
| FLUVALAB | Active comparator | One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens Receives: Biological: Vaccination with FluvalAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of immunogenicity
The measures of immunogenicity (by using HI test) are:
- the GMTs at Day 0 and at Day 21
- the Day 21/Day 0 geometric mean titer ratios (GMTRs)
- the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 21
- the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 21.
Measured: 21-28 days following vaccination
Measures of safety
The measures of safety are:
Number and percentage of subjects with at least
- one local reaction between Day 0 and Day 7
- one systemic reaction between Day 0 and Day 7
- one adverse event between Day 0 and visit at Day 21.
Measured: 21-28 days following vaccination
Secondary outcomes (2)
Measures of long term immunogenicity
The measures of long term immunogenicity (by using HI test) are:
- the GMTs at Day 0 and at Day 120
- the Day 120/Day 0 geometric mean titer ratios (GMTRs)
- the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 120
- the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 120.
Measured: 110-120 days following vaccination
Measures of long term safety
The measures of long term safety are:
Number and percentage of subjects with at least
- one local reaction
- one systemic reaction
- one adverse event between Day 0 and visit at Day 120.
Measured: 110-120 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 posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionMar 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabor Kollar, MD, Study director, Omninvest LtdFerenc Tamás, MD, Principal investigator, Family Doctor's Office, PilisvörösvárÁgnes Hasitz, MD, Principal investigator, Family Doctor's Office, SzentendreJudit Simon, MD, Principal investigator, Family Doctor's Office, BudapestBarna Bőze, MD, Principal investigator, Family Doctor's Office, HatvanTibor Hrutka, MD, Principal investigator, Family Doctor's Office, VecsésPéter Torzsa, MD, Principal investigator, Family Doctor's Office, BudapestPéter Vajer, MD, Principal investigator, Family Doctor's Office, Biatorbágy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459276
- Sponsor's protocol ID
- FluvalAB-H-15
- Other IDs
- 2011-003314-16
- Status last verified
- May 2012
- First submitted
- 19 Oct 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
- A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6μgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01459276
- Acronym / sponsor ID
- FluvalAB-H-15
- Conditions
- Influenza
- Keywords
- seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Oct 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 one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAB-6011 | Experimental | Biological: Vaccination with FAB-6011One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens |
| FLUVALAB | Active comparator | Biological: Vaccination with FluvalABOne 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male and female adult volunteers aged 18 years or older,
- mentally competent,
- able to understand and comply with all study requirements,
- willing and able to give written informed consent prior to initiation of study procedures,
- in good health (as determined by clinical judgement of the investigator on the basis of medical history 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.
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.
- Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
- History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
- History of Guillain-Barré syndrome;
- 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 FAB-6011Also: FAB-6011One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. | Biological | FAB-6011 |
| Vaccination with FluvalABAlso: FluvalABOne 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. | Biological | FLUVALAB |
Primary outcome
Measures of immunogenicity
Time frame: 21-28 days following vaccination
The measures of immunogenicity (by using HI test) are: * the GMTs at Day 0 and at Day 21 * the Day 21/Day 0 geometric mean titer ratios (GMTRs) * the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 21 * the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 21.
Measures of safety
Time frame: 21-28 days following vaccination
The measures of safety are: Number and percentage of subjects with at least * one local reaction between Day 0 and Day 7 * one systemic reaction between Day 0 and Day 7 * one adverse event between Day 0 and visit at Day 21.
2 secondary outcomes
Measures of long term immunogenicity
Time frame: 110-120 days following vaccination
Measures of long term safety
Time frame: 110-120 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.
Gabor Kollar, MD study director
Omninvest Ltd
Ferenc Tamás, MD principal investigator
Family Doctor's Office, Pilisvörösvár
Ágnes Hasitz, MD principal investigator
Family Doctor's Office, Szentendre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination with FAB-6011 and Vaccination with FluvalAB in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 7 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 7 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 7 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.
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?
Measures of immunogenicity (time frame: 21-28 days following vaccination). The study lists 2 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 21 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.