InfluenzaNCT00778297

Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

A study testing Vaccination with FluvalAB FL-K-004 trivalent flu vaccine and Vaccination with FluvalAB trivalent influenza vaccine in people with Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability. 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 FluvalAB FL-K-004 trivalent flu vaccine and Vaccination with FluvalAB trivalent influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 1 siteHungary
Study dates: Nov 2007to May 2008
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

Adult volunteers in good health aged over 18 years, both sexes;
Full contractual capacity of the participants;
Are in good health (as determined by vital signs and medical history);
Negative urine or serum pregnancy test for females of childbearing potential;
Are able to understand and comply with planned study procedures;
Signed 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;
History of Guillain-Barré syndrome;
Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
Immunosuppressive therapy in the preceding 36 months;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
Concomitant corticosteroid therapy, including inhaled corticosteroids;

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Psychiatric illness and/or concomitant psychiatric drug therapy;
Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
Vaccine therapy within 4 weeks prior to the study;
Influenza vaccination within 6 months prior to the study;
Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
Documented HIV, HBV or HCV infection;
Acute febrile respiratory illness within one week prior to vaccination;
Experimental drug therapy within 1 month prior to vaccination;
Alcohol or drug abuse.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

Pilisvörösvár District Doctor's Office
Pilisvörösvár, 2085

Other trials in Hungary

About this study

Official title: Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content

The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.

Conditions: Influenza
Being tested: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine, Vaccination with FluvalAB trivalent influenza vaccine
Keywords: prevention, influenza, infection, vaccine, Influenza 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 FluvalAB FL-K-004 trivalent flu vaccineBiological
Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).
Vaccination with FluvalAB trivalent influenza vaccineBiological
Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).

Study groups in NCT00778297
Study group	Role	What they receive
Group 1	Experimental	Not described Receives: Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine
Group 2	Active comparator	Not described Receives: Biological: Vaccination with FluvalAB trivalent influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-vaccination HI antibody titre
Measured: 21-28 days after vaccination
Incidence of adverse reactions
Measured: 21-28 days after vaccination

Secondary outcomes (1)

Post-vaccination HI antibody titer
Measured: 110-120 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007May 2008

First posted23 Oct 2008 (estimated)
Study startNov 2007
Primary completionJan 2008
Study completionMay 2008

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: Single blind
Who is masked: Participant
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00778297
Sponsor's protocol ID: FluvalAB-H-05
Other IDs: OGYI 28438/82/07, EudraCT 2007-004239-52
Status last verified: May 2012
First submitted: 22 Oct 2008
Last updated: 21 May 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content
ClinicalTrials.gov ID: NCT00778297
Acronym / sponsor ID: FluvalAB-H-05
Conditions: Influenza
Keywords: prevention, influenza, infection, vaccine, Influenza vaccine, Influenza in humans
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jan 2008 (actual)
Study completion: May 2008 (actual)
First posted: 23 Oct 2008 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine
Group 2	Active comparator	Biological: Vaccination with FluvalAB trivalent influenza vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adult volunteers in good health aged over 18 years, both sexes;
Full contractual capacity of the participants;
Are in good health (as determined by vital signs and medical history);
Negative urine or serum pregnancy test for females of childbearing potential;
Are able to understand and comply with planned study procedures;

Key exclusion criteria (15 listed)

Known allergy to eggs or other components of the vaccine;
History of Guillain-Barré syndrome;
Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
Immunosuppressive therapy in the preceding 36 months;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);

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 FluvalAB FL-K-004 trivalent flu vaccineTreatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).	Biological	Group 1
Vaccination with FluvalAB trivalent influenza vaccineTreatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).	Biological	Group 2

Primary outcome

Post-vaccination HI antibody titre
Time frame: 21-28 days after vaccination
Incidence of adverse reactions
Time frame: 21-28 days after vaccination

1 secondary outcome

Post-vaccination HI antibody titer
Time frame: 110-120 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.

Ferenc Tamás, MD principal investigator

Pilisvörösvár District Doctor's Office

Zsuzsa Galambos, MD study director

Omninvest Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 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?

Post-vaccination HI antibody titre (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 NCT00778297.

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.