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Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

Seasonal Influenza Clinical Trial

Official title:
A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

Clinical Trial Summary

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. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01161264
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date July 2010
Completion date July 2010
View Details
See also
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