A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

PHASE3CompletedINTERVENTIONAL
Enrollment

3,109

Participants

Timeline

Start Date

October 1, 2010

Primary Completion Date

July 1, 2011

Study Completion Date

July 1, 2011

Conditions
Influenza
Interventions
BIOLOGICAL

Quadrivalent seasonal influenza vaccine GSK2282512A

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

BIOLOGICAL

Fluarix™ VB

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

BIOLOGICAL

Fluarix™ YB

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

BIOLOGICAL

Quadrivalent seasonal influenza vaccine GSK2282512A

Single intramuscular dose for primed subjects, two doses for unprimed subjects.

Trial Locations (33)

100

GSK Investigational Site, Taipei

404

GSK Investigational Site, Taichung

16148

GSK Investigational Site, Hermitage

28046

GSK Investigational Site, Madrid

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

29812

GSK Investigational Site, Barnwell

37043

GSK Investigational Site, Clarksville

41014

GSK Investigational Site, Seville

41500

GSK Investigational Site, Alcalá de Guadaira

49120

GSK Investigational Site, Niles

63141

GSK Investigational Site, St Louis

64460

GSK Investigational Site, Monterrey

68131

GSK Investigational Site, Omaha

72205

GSK Investigational Site, Little Rock

72432

GSK Investigational Site, Harrisburg

76135

GSK Investigational Site, Fort Worth

80112

GSK Investigational Site, Centennial

80233

GSK Investigational Site, Thornton

80501

GSK Investigational Site, Longmont

85224

GSK Investigational Site, Chandler

85288

GSK Investigational Site, Scottsdale

90723

GSK Investigational Site, Paramount

92647

GSK Investigational Site, Huntington Beach

T6G 2C8

GSK Investigational Site, Edmonton

V3R 8P8

GSK Investigational Site, Surrey

R3A 1M3

GSK Investigational Site, Winnipeg

A1N 5B6

GSK Investigational Site, Mount Pearl

B3K 6R8

GSK Investigational Site, Halifax

L6T 0G1

GSK Investigational Site, Brampton

P3E 1H5

GSK Investigational Site, Greater Sudbury

L8L 5G8

GSK Investigational Site, Hamilton

S7K 3H3

GSK Investigational Site, Saskatoon

04530

GSK Investigational Site, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01198756 - A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children | Biotech Hunter | Biotech Hunter