Extrait

To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in adult and 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).

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 risk and elderly. Agrippal is a subunit inactivated influenza vaccine,purifeid,registered in Italy since 1986,recommended in the prevention of influenza in subjects from 6 months of age, in particular in subject at high risk for associated complications

Liens

• ictrp
• euctr