InfluenzaNCT01010893
Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine
A study testing Vaccination with Fluval P and Fluval AB influenza vaccines and Vaccination with Fluval P monovalent influenza vaccine in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 2 sites in Hungary.
Trial summary
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug. 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 P and Fluval AB influenza vaccines and Vaccination with Fluval P monovalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 2 sitesHungary
- Study dates
- Aug 2009to Feb 2010
- 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
- Adults aged 18 to 60 years, elderly people aged over 60 years, from both sexes, with full contractual capacity;
- 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;
- Femal volunteers 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.
- Capable of understanding and complying with study protocol requirements;
- The volunteers provide written informed consent prior to initiation of study procedures;
- Absence of existence of any exclusion criteria.
Who cannot join
- Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
- Known allergy to eggs or other components of the vaccine (in particular mercury);
- History of Guillain-Barré syndrome;
- Active neoplasm;
- Immunosuppressive therapy in the preceding 36 months;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
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- Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
- Documented HIV, HBV or HCV infection;
- Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse;
- Acute febrile respiratory illness within one week prior to vaccination;
- Vaccine therapy within 4 weeks prior to vaccination;
- Influenza vaccination within 6 months prior to vaccination;
- Experimental drug therapy within 1 month prior to vaccination;
- 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
District Doctor's Office
Pilisvörösvár, H-2085
Fourmed Kft. Gyogyhaz
Veszprém, H-8200
About this study
Official title: Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
Read the detailed description
Primary Objective:
To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.
To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.
- Conditions
- Influenza
- Being tested
- Vaccination with Fluval P and Fluval AB influenza vaccines, Vaccination with Fluval P monovalent influenza vaccine
- Keywords
- pandemic, 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 P and Fluval AB influenza vaccinesBiological
Also called Influenza, Pandemic vaccine, Seasonal vaccine, Co-vaccination
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Vaccination with Fluval P monovalent influenza vaccineBiological
Also called pandemic, influenza, prevention, vaccine
Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination | Experimental | Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose). Receives: Biological: Vaccination with Fluval P monovalent influenza vaccine |
| Influenza vaccination and co-vaccination | Experimental | Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose). Receives: Biological: Vaccination with Fluval P and Fluval AB influenza vaccines |
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 after vaccination
Incidence of adverse reactions
Measured: 21-28 days after vaccination
Secondary outcomes (1)
Incidence of adverse reactions
Measured: 50-60 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 posted10 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferenc Tamas, MD, Principal investigator, Pilisvorosvar District Doctor's OfficeAnna Osi, Dr., Study director, Omninvest Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010893
- Sponsor's protocol ID
- FLUVAL P-H-06
- Status last verified
- May 2012
- First submitted
- 7 Nov 2009
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.
PubMed 20018367
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 P Monovalent Influenza Vaccine in Adults and Elderly Persons
- ClinicalTrials.gov ID
- NCT01010893
- Acronym / sponsor ID
- FLUVAL P-H-06
- Conditions
- Influenza
- Keywords
- pandemic, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Nov 2009 (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.
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
Detailed description
Primary Objective:
To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.
To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination | Experimental | Biological: Vaccination with Fluval P monovalent influenza vaccineVaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose). |
| Influenza vaccination and co-vaccination | Experimental | Biological: Vaccination with Fluval P and Fluval AB influenza vaccinesVaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose). |
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 people aged over 60 years, from both sexes, with full contractual capacity;
- 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;
- Femal volunteers 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.
- Capable of understanding and complying with study protocol requirements;
- The volunteers provide written informed consent prior to initiation of study procedures;
Key exclusion criteria (15 listed)
- Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
- Known allergy to eggs or other components of the vaccine (in particular mercury);
- History of Guillain-Barré syndrome;
- Active neoplasm;
- Immunosuppressive therapy in the preceding 36 months;
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 P and Fluval AB influenza vaccinesAlso: Influenza, Pandemic vaccine, Seasonal vaccine, Co-vaccinationVaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose). | Biological | Influenza vaccination and co-vaccination |
| Vaccination with Fluval P monovalent influenza vaccineAlso: pandemic, influenza, prevention, vaccineFluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant | Biological | Influenza vaccination |
Primary outcome
Post vaccination HI antibody titer
Time frame: 21-28 days after vaccination
Incidence of adverse reactions
Time frame: 21-28 days after vaccination
1 secondary outcome
Incidence of adverse reactions
Time frame: 50-60 days after 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.
- Derived from this study: PubMed 20018367Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.
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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 Tamas, MD principal investigator
Pilisvorosvar District Doctor's Office
Anna Osi, Dr. study director
Omninvest Ltd.
2 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 Fluval P and Fluval AB influenza vaccines and Vaccination with Fluval P monovalent 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 15 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.
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 after 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?
On the ClinicalTrials.gov record for NCT01010893, which also lists 1 linked publication.
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.