A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

NCT01357265 Phase 2 COMPLETED

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	COMPLETED
Enrolment	125
Start date	2011-05
Completion	2011-06

Conditions

• Influenza

Interventions

• Seasonal Influenza Vaccine

Primary outcomes

• To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly — 22 days including follow-up period
  To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Countries

Italy