Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age

PHASE1CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 29, 2006

Primary Completion Date

November 1, 2006

Study Completion Date

November 16, 2006

Conditions
Influenza
Interventions
BIOLOGICAL

Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

BIOLOGICAL

Influenza Monovalent Whole virus (H5N1)

2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21

Trial Locations (9)

21255

GSK Investigational Site, Tostedt

23795

GSK Investigational Site, Bad Segeberg

25335

GSK Investigational Site, Elmshorn

03238

GSK Investigational Site, Finsterwalde

01129

GSK Investigational Site, Dresden

01307

GSK Investigational Site, Dresden

09599

GSK Investigational Site, Freiberg

09326

GSK Investigational Site, Geringswalde

01762

GSK Investigational Site, Schmiedeberg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY