drugset / Trial / NCT00956449

Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects

NCT00956449

Phase 2 Completed 126 enrolled Novartis Novartis Vaccines · collab
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Timeline

Start
2009-06
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent influenza vaccine Vaccine

Indications