Immunization of children 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 6 to 36 months, 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; The legitimate representative of the volunteer is able to understand and comply with planned study procedures; The legitimate representative of the volunteer provides 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: Known allergy to eggs or other components of the vaccine (in particular mercury); History of Guillain-Barré syndrome; Active neoplasm; Former or on-going immunosuppressive therapy; 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 have effect on the participation in the study; 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 legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative; Alcohol or drug abuse of the legitimate representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess tolerability/safety (incidence of adverse events) of the study drug after Day 10. following the vaccination.;Secondary Objective: To assess the long-term safety of the study drug 50-60 days after immunization. To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.;Primary end point(s): Assessment tolerability/safety (incidence of adverse events) of the study drug after Day 10. following the vaccination. Assessment of the long-term safety of the study drug 50-60 days after immunization. Assessment of the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season. | — |
Countries
Hungary
Outcome results
None listed