Immunization of healthy people against influenza virus infection MedDRA version: 14.0 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Fluval AB-like influenza vaccine
Product Code: FAB-6011
Pharmaceutical Form: Suspension for injection
Other descriptive name: A/California/7/2009(H1N1)-like NYMC X-179A reass. strain
Con
Sponsors
Omninvest Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects eligible for enrolment into this study are: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 504 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 728
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. • Hypersensivity 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.;Secondary Objective: Secondary immunogenicity objectives a) To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 120 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96. b) To assess non-inferiority of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens against FLUVAL AB trivalent influenza vaccine containing 15µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in terms of post-immunization GMTs as measured by HI test 21 and 120 days after vaccination. Safety and tolerability objective To evaluate the safety of the administration of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.;Primary end point(s): To justify immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.;Timepoint(s) of evaluation of this end point: 21 days following vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary immunogenicity end points: a) To justify immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 120 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96. b) To justify non-inferiority of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens against FLUVAL AB trivalent influenza vaccine containing 15µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in terms of post-immunization GMTs as measured by HI test 21 and 120 days after vaccination. Safety and tolerability end point: To justify the safety of the administration of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.;Timepoint(s) of evaluation of this end point: Secondary immunogenicity end points: 21 days and 120 days following vaccination. Safety and tolerability end point: Local and systemic reactions and other adverse events will be collected throughout the study. | — |
Countries
Hungary
Outcome results
None listed