Extrait

Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines, CPMP/BWP/214/96: 12 March 1997). Safety Objectives To evaluate the safety of a single intramuscular (IM) injection of FLUAD in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).

Critère d'inclusion

• Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations

Liens

• ictrp
• euctr