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Influenza (Flu) is an important health problem for many people in the world and is one of the top causes of death.A vaccine is given because it may prevent getting a disease. Fluvirin is an influenza ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2011-006271-18

Influenza (Flu) is an important health problem for many people in the world and is one of the top causes of death.A vaccine is given because it may prevent getting a disease. Fluvirin is an influenza vaccine that is registered medicine and commercially available in the pharmacies every year from the start of the flu season

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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

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