Immunization of healthy children and adolescents against influenza virus infection MedDRA version: 14.1 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 100000004865
Conditions
Interventions
Product Name: Fluval AB Novo Suspension for Injection
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A
Other descriptive name: A/CALIFOR
Sponsors
Omninvest Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children aged 3 to 12 years, adolescents aged 12 to 18 years from 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; • Female volunteers 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; • Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures; • Adolescent participants aged 12 to 18 years and legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures; • Absence of existence of any exclusion criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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. • Known hypersensitivity to eggs, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine; • History of Guillain-Barré syndrome; • History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; • 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 36 months prior to vaccination; • Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids; • Receipt of immunostimulants; • Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination; • Suspected or known HIV, HBV or HCV infection; • Acute disease and/or axillary temperature =37oC within 3 days prior to vaccination; • Vaccine therapy within 4 weeks prior to vaccination; • Influenza vaccination (any kind) within 6 months prior to vaccination; • Experimental drug therapy within 4 weeks prior to vaccination; • 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 volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer; • Alcohol or drug abuse of the participant or the legitimate representative.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability objectives: A brief medical history will be obtained and physical examination performed for each subject entered into the study. Local and systemic reactions and other adverse events will be collected throughout the study. ;Timepoint(s) of evaluation of this end point: 21-28 days after vaccination | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of immunogenicity of the vaccine by serology testing from blood samples taken before 21-28 days after vaccination.;Secondary Objective: Assessment of safety and tolerability of the vaccine on the basis of adverse events.;Primary end point(s): The measures of immunogenicity, for all evaluable subjects by using HI test are: •the geometric mean titres (GMTs) at Day 0 and at Day 21-28 as determined by HI; •the Day 21-28/Day 0 geometric mean titre ratios (GMTRs) as determined by HI; •the percentage of subjects achieving seroconversion or significant increase in antibody titre at Day 21-28 after vaccination as determined by HI; •the percentage of subjects achieving a titre =40 at Day 0 and at Day 21-28 as determined by HI.;Timepoint(s) of evaluation of this end point: 21-28 days after vaccination | — |
Countries
Hungary
Contacts
Public ContactStudy director
Omninvest Ltd.
Outcome results
None listed