Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
125
Werksarztzentrum Herborn, Westerwaldstr 36,
Herborn, Germany
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
Marburg, Germany
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting
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