A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Vaccination with FAB-6011
* Biological: Vaccination with FluvalAB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAB-6011<br>One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens | Biological: Vaccination with FAB-6011<br>* One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.<br>* Other names: FAB-6011;|
| Active Comparator: FLUVALAB<br>One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens | Biological: Vaccination with FluvalAB<br>* One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.<br>* Other names: FluvalAB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of immunogenicity | The measures of immunogenicity (by using HI test) are: the GMTs at Day 0 and at Day 21 the Day 21/Day 0 geometric mean titer ratios (GMTRs) the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 21 the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 21. | 21-28 days following vaccination | 
| Measures of safety | The measures of safety are: Number and percentage of subjects with at least one local reaction between Day 0 and Day 7 one systemic reaction between Day 0 and Day 7 one adverse event between Day 0 and visit at Day 21. | 21-28 days following vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of long term immunogenicity | The measures of long term immunogenicity (by using HI test) are: the GMTs at Day 0 and at Day 120 the Day 120/Day 0 geometric mean titer ratios (GMTRs) the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 120 the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 120. | 110-120 days following vaccination | 
| Measures of long term safety | The measures of long term safety are: Number and percentage of subjects with at least one local reaction one systemic reaction one adverse event between Day 0 and visit at Day 120. | 110-120 days following vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans