Immunogenicity, Safety, and Tolerability of Two Trivalent Subunit Inactivated Influenza Vaccines: A Phase III, Observer-Blind, Randomized, Controlled Multicenter Study

Abstract The objective of this study was to evaluate and compare the immunogenicity, safety, and tolerability of two influenza subunit vaccines, a primarily European-marketed trivalent vaccine (Agrippal®, Novartis Vaccines), and a predominantly U.S.-marketed control trivalent vaccine (Fluvirin®, Novartis Vaccines), in subjects aged 3–64 y. The immunogenicity of both vaccines was evaluated according to the Center for Biologics Evaluation and Research (CBER) criteria. This clinical trial was performed between April and December 2007 in Argentina. A total of 1893 subjects were stratified into three age groups (3–8 y, 9–17 y, and 18–64 y), and randomized in a 2:1 ratio to receive either Agrippal or Fluvirin. Adolescents and adults received one dose of vaccine intramuscularly, whereas children aged 3–8 years received two vaccine doses, administered 4 wk apart. Antibody levels were measured by means of hemagglutination inhibition assay before vaccination (baseline); 21 d after the first vaccination (adults and ...