Influenza ProphylaxisPhase 4NCT01863849
Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
A Phase 4 study testing Vaccination with Fluval AB suspension for injection in people with Influenza Prophylaxis, run by Fluart Innovative Vaccine Ltd, Hungary at 3 sites in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Prophylaxis
- What is being tested?
- Vaccination with Fluval AB suspension for injection
- 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
- 22 Aug 2013to 17 Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- 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 (IC) 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;
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 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
Family Doctor's Office
Budapest, 1083
District Doctor's Office
Pilisvörösvár, 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 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects
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.
Read the detailed description
Aim of the study:
To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997
Primary objective:
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 test.
Methods:
In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group:
Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions.
All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that.
All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity was evaluated by HI test.
- Conditions
- Influenza Prophylaxis
- Being tested
- Vaccination with Fluval AB suspension for injection
- Keywords
- uncontrolled, open, multi-centre, immunogenicity and tolerability, two groups according to age (18-59 years and ≥60 years)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with Fluval AB suspension for injectionBiological
Single intramuscular injection with Fluval AB suspension for injection in both age groups
| Study group | Role | What they receive |
|---|---|---|
| Age group 1: adults (18-59 years) | Experimental | Intervention: Vaccination with Fluval AB suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Receives: Biological: Vaccination with Fluval AB suspension for injection |
| Age group 2: elderly (> 60 years) | Experimental | Intervention: Vaccination with Fluval AB suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Receives: Biological: Vaccination with Fluval AB suspension for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Geometric Mean Titre Ratio, A/H1N1 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Measured: 21-28 days after vaccination
Change in Geometric Mean Titre Ratio, A/H3N2 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Measured: 21-28 days after vaccination
Change in Geometric Mean Titre Ratio, B Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Measured: 21-28 days after vaccination
Seroconversion, A/H1N1 Strain
Percentage of subjects seroconverted or had a significant increase in titres
Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Measured: 21-28 days after vaccination
Seroconversion, A/H3N2 Strain
Percentage of subjects seroconverted or had a significant increase in titres
Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Measured: 21-28 days after vaccination
Seroconversion, B Strain
Percentage of subjects seroconverted or had a significant increase in titres
Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Measured: 21-28 days after vaccination
Seroprotection, A/H1N1 Strain
Percentage of subjects seroprotected
Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Measured: 21-28 days after vaccination
Seroprotection, A/H3N2 Strain
Percentage of subjects seroprotected
Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Measured: 21-28 days after vaccination
Seroprotection, B Strain
Percentage of subjects seroprotected
Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Measured: 21-28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study start22 Aug 2013
- Primary completion17 Sep 2013
- Study completion17 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza ProphylaxisStudies 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
- Parallel groups
- Model description
- parallel-group, in two age groups
- 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
- Zsolt Németh, Study chair, Fluart Innovative Vaccines Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863849
- Sponsor's protocol ID
- FluvalAB-H-YL2013
- Status last verified
- Mar 2021
- First submitted
- 23 May 2013
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. 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 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01863849
- Acronym / sponsor ID
- FluvalAB-H-YL2013
- Conditions
- Influenza Prophylaxis
- Keywords
- uncontrolled, open, multi-centre, immunogenicity and tolerability, two groups according to age (18-59 years and ≥60 years)
- 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
- 22 Aug 2013
- Primary completion
- 17 Sep 2013 (actual)
- Study completion
- 17 Sep 2013 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim of the study:
To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997
Primary objective:
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 test.
Methods:
In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group:
Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions.
All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that.
All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity was evaluated by HI test.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group, in two age groups
| Arm | Type | Receives |
|---|---|---|
| Age group 1: adults (18-59 years) | Experimental | Biological: Vaccination with Fluval AB suspension for injectionIntervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. |
| Age group 2: elderly (> 60 years) | Experimental | Biological: Vaccination with Fluval AB suspension for injectionIntervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. |
Who may qualify
- Ages
- 18 to 99 years
- 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 (IC) 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 |
|---|---|---|
| Vaccination with Fluval AB suspension for injectionSingle intramuscular injection with Fluval AB suspension for injection in both age groups | Biological | Age group 1: adults (18-59 years), Age group 2: elderly (> 60 years) |
Primary outcome
Change in Geometric Mean Titre Ratio, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Change in Geometric Mean Titre Ratio, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Change in Geometric Mean Titre Ratio, B Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Seroconversion, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Seroconversion, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Seroconversion, B Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %
Seroprotection, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Seroprotection, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Seroprotection, B Strain
Time frame: 21-28 days after vaccination
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Zsolt Németh study chair
Fluart Innovative Vaccines Ltd.
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 Vaccination with Fluval AB suspension for injection in people with Influenza Prophylaxis, 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 5 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Geometric Mean Titre Ratio, A/H1N1 Strain (time frame: 21-28 days after vaccination). The study lists 9 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 5 Apr 2021.