- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459276
A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects
May 18, 2012 updated by: Fluart Innovative Vaccine Ltd, Hungary
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1206
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Budapest, Hungary, 1083
- Family Doctor's Office
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Budapest, Hungary, 1136
- Family Doctor's Office
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Pilisvörösvár, Hungary, 2085
- Family Doctor's Office
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Pest
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Biatorbágy, Pest, Hungary, 2051
- Péter Vajer
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Hatvan, Pest, Hungary, 3000
- Barna Bőze
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Szentendre, Pest, Hungary, 2000
- Family Doctor's Office
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Vecsés, Pest, Hungary, 2220
- Tibor Hrutka
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FAB-6011
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens
|
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
Other Names:
|
Active Comparator: FLUVALAB
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens
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One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of immunogenicity
Time Frame: 21-28 days following vaccination
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The measures of immunogenicity (by using HI test) are:
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21-28 days following vaccination
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Measures of safety
Time Frame: 21-28 days following vaccination
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The measures of safety are: Number and percentage of subjects with at least
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21-28 days following vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of long term immunogenicity
Time Frame: 110-120 days following vaccination
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The measures of long term immunogenicity (by using HI test) are:
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110-120 days following vaccination
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Measures of long term safety
Time Frame: 110-120 days following vaccination
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The measures of long term safety are: Number and percentage of subjects with at least
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110-120 days following vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Gabor Kollar, MD, Omninvest Ltd
- Principal Investigator: Ágnes Hasitz, MD, Family Doctor's Office, Szentendre
- Principal Investigator: Judit Simon, MD, Family Doctor's Office, Budapest
- Principal Investigator: Péter Torzsa, MD, Family Doctor's Office, Budapest
- Principal Investigator: Ferenc Tamás, MD, Family Doctor's Office, Pilisvörösvár
- Principal Investigator: Barna Bőze, MD, Family Doctor's Office, Hatvan
- Principal Investigator: Tibor Hrutka, MD, Family Doctor's Office, Vecsés
- Principal Investigator: Péter Vajer, MD, Family Doctor's Office, Biatorbágy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
October 19, 2011
First Submitted That Met QC Criteria
October 21, 2011
First Posted (Estimate)
October 25, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 18, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FluvalAB-H-15
- 2011-003314-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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