InfluenzaNCT01100294
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
A study testing Vaccination with FLUVAL P in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site in Hungary.
Trial summary
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccination with FLUVAL P
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2009to May 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 36 months, both sexes;
- 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;
- Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
- Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;
- Absence of existence of any exclusion criteria.
Who cannot join
- Known allergy to eggs or other components of the vaccine (in particular mercury);
- History of Guillain-Barré syndrome;
- Active neoplasm;
- Former or on-going immunosuppressive therapy;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
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- Documented HIV, HBV or HCV infection;
- Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;
- 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 legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;
- Alcohol or drug abuse of the legitimate representative.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
"Csolnoky Ferenc" Veszprém County Hospital
Veszprém, Veszprém megye, 8200
About this study
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
Read the detailed description
This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.
Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
- Conditions
- Influenza
- Being tested
- Vaccination with FLUVAL P
- Keywords
- Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with FLUVAL PBiological
Also called Influenza, Pandemic vaccine, Prevention, Influenza vaccine
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
Dose: 0.25 ml (total 3 μg HA), single dose.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination with Fluval P | Experimental | Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose. Receives: Biological: Vaccination with FLUVAL P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.
Measured: 28 days after vaccination
Secondary outcomes (2)
Incidence of adverse events
To assess safety of the study drug after Day 180-210 following the vaccination.
Measured: 180-210 days after vaccination
Efficacy of the study drug
To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.
Measured: 180-210 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 posted8 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionMay 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Ősi, Dr., Study director, Omninvest Ltd.Éva Szabó, MD, Principal investigator, "Csolnoky Ferenc" Veszprém County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100294
- Sponsor's protocol ID
- FLUVAL P-H-08
- Status last verified
- May 2012
- First submitted
- 30 Mar 2010
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
- ClinicalTrials.gov ID
- NCT01100294
- Acronym / sponsor ID
- FLUVAL P-H-08
- Conditions
- Influenza
- Keywords
- Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Apr 2010 (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 safety of FLUVAL P monovalent influenza vaccine in children.
Detailed description
This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.
Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination with Fluval P | Experimental | Biological: Vaccination with FLUVAL PVaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 36 months, both sexes;
- 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;
- Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
- Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;
- Absence of existence of any exclusion criteria.
Key exclusion criteria (14 listed)
- Known allergy to eggs or other components of the vaccine (in particular mercury);
- History of Guillain-Barré syndrome;
- Active neoplasm;
- Former or on-going immunosuppressive therapy;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
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 PAlso: Influenza, Pandemic vaccine, Prevention, Influenza vaccineVaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose. | Biological | Vaccination with Fluval P |
Primary outcome
Incidence of adverse events
Time frame: 28 days after vaccination
To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.
2 secondary outcomes
Incidence of adverse events
Time frame: 180-210 days after vaccination
Efficacy of the study drug
Time frame: 180-210 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.
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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.
Anna Ősi, Dr. study director
Omninvest Ltd.
Éva Szabó, MD principal investigator
"Csolnoky Ferenc" Veszprém County Hospital
1 site 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 in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site 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 5 inclusion and 14 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 1 site 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?
Incidence of adverse events (time frame: 28 days after 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.