A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, when Administered ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-018583-17

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, when Administered to Non-elderly Adult and Elderly Subjects

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Extrait

To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.


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

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