Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

PHASE2CompletedINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

November 10, 2008

Primary Completion Date

August 19, 2009

Study Completion Date

August 19, 2009

Conditions
Influenza
Interventions
BIOLOGICAL

GSK Biologicals' influenza vaccine GSK1557482A

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

BIOLOGICAL

Vaxigrip

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Trial Locations (18)

T3B 6A8

GSK Investigational Site, Calgary

V3A 4H9

GSK Investigational Site, Langley

R3E 3P4

GSK Investigational Site, Winnipeg

A1N 5B6

GSK Investigational Site, Mount Pearl

B3K 6R8

GSK Investigational Site, Halifax

P3E 1H5

GSK Investigational Site, Greater Sudbury

L8L 5G8

GSK Investigational Site, Hamilton

N6A 5R9

GSK Investigational Site, London

N6H 4P2

GSK Investigational Site, London

L5A 3V4

GSK Investigational Site, Mississauga

L3Y 5G8

GSK Investigational Site, Newmarket

N7T 4X3

GSK Investigational Site, Sarnia

M5G 1N8

GSK Investigational Site, Toronto

C1A 5N4

GSK Investigational Site, Charlottetown

H3T 1C5

GSK Investigational Site, Montreal

G1V 4M6

GSK Investigational Site, Québec

G1X 3V7

GSK Investigational Site, Ste-Foy

G8T 7A1

GSK Investigational Site, Trois-Rivières

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY