Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age

PHASE1CompletedINTERVENTIONAL
Enrollment

427

Participants

Timeline

Start Date

August 26, 2013

Primary Completion Date

November 1, 2013

Study Completion Date

October 20, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

Investigational H7N1 vaccine GSK2789869A

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

BIOLOGICAL

Investigational H7N1 vaccine GSK2789868A

One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

BIOLOGICAL

Placebo

One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21

Trial Locations (9)

14609

GSK Investigational Site, Rochester

30281

GSK Investigational Site, Stockbridge

33143

GSK Investigational Site, Miami

44122

GSK Investigational Site, Cleveland

78705

GSK Investigational Site, Austin

89104

GSK Investigational Site, Las Vegas

B2N 1L2

GSK Investigational Site, Truro

P3E 1H5

GSK Investigational Site, Greater Sudbury

M9W 4L6

GSK Investigational Site, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY