Influenza Clinical Trial
Official title:
Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
Primary Objective:
To assess tolerability/safety (incidence of adverse events) of the study drug. 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.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine
the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza
vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly
people.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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