Influenza, Human Clinical Trial
Official title:
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents
This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology testing.
Primary Objective:
- To assess tolerability/safety (incidence of adverse events 21-28 days following
vaccination) of the study drug.
Secondary Objectives:
- 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 age groups.
- To assess long term (180-210 days following vaccination) tolerability/safety (incidence
of adverse events) of the study drug.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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