Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10

PHASE2CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2009

Conditions
Pandemic Influenza Disease
Interventions
BIOLOGICAL

Monovalent A/H1N1 influenza vaccine

This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.

Trial Locations (5)

Unknown

01, Chieti

05, Ferrara

04, Genova

02, Lanciano

03, Mira 30034 Pianiga,

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY