Femme et Homme
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Extrait
Safety Objectives: To evaluate the safety of a single intramuscular (IM) injection of Fluvirin 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 (CPMP/BWP/214/96). Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 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 Single Radial Hemolysis (SRH) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).
Critère d'inclusion
- Prophylaxis of influenza