Immunization of children and adolescents against infection caused by pandemic influenza (H1N1)09 virus. MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Sponsors
Omninvest Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children aged 3 to 12 years, adolescents aged 12 to 18 years, both sexes; Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition with adequately treated systemic diseasis (e.g. asthma or diabetes), not enlisted as exclusion criteria, upon judgement of the investigator; Negative urine pregnancy test for femal volunteers of childbearing potential. If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. The legitimate representative of all volunteers and adolescent participants aged 12 to 18 years are able to understand and comply with planned study procedures; The legitimate representative of all volunteers and adolescent participants aged 12 to 18 years provide written informed consent 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: 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 or breast feeding or positive pregnancy test prior to vaccination; Known allergy to eggs or other components of the vaccine (in particular mercury); History of Guillain-Barré syndrome; Active neoplasm; Immunosuppressive therapy in the preceding 36 months; Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids; Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; Documented HIV, HBV or HCV infection; Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse; Acute febrile respiratory illness within one week prior to vaccination; Vaccine therapy within 4 weeks prior to vaccination; Influenza vaccination within 6 months prior to vaccination; Experimental drug therapy within 1 month prior to vaccination; Existing or former psychiatric illness of the volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer or the legitimate representative; Alcohol or drug abuse of the participant or the legitimate representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess tolerability/safety (incidence of adverse events) of the study drug.;Secondary Objective: To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and in age groups. To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season. To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.;Primary end point(s): Assessment of tolerability/safety (incidence of adverse events) of the study drug. Assessment of the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and in age groups. | — |
Countries
Hungary
Outcome results
None listed