Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

2,432

Participants

Timeline

Start Date

October 1, 2014

Primary Completion Date

March 16, 2015

Study Completion Date

June 23, 2015

Conditions
Influenza
Interventions
BIOLOGICAL

FluLaval™ Quadrivalent

1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively

BIOLOGICAL

Fluzone® Quadrivalent

1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively

Trial Locations (66)

13210

GSK Investigational Site, Syracuse

13901

GSK Investigational Site, Binghamton

16148

GSK Investigational Site, Hermitage

16505

GSK Investigational Site, Erie

18960

GSK Investigational Site, Sellersville

19107

GSK Investigational Site, Philadelphia

21045

GSK Investigational Site, Columbia

22902

GSK Investigational Site, Charlottesville

27609

GSK Investigational Site, Raleigh

29406

GSK Investigational Site, Charleston

29520

GSK Investigational Site, Cheraw

32736

GSK Investigational Site, Lake Mary

33014

GSK Investigational Site, Miami Lakes

35235

GSK Investigational Site, Birmingham

36305

GSK Investigational Site, Dothan

37660

GSK Investigational Site, Kingsport

40291

GSK Investigational Site, Louisville

44121

GSK Investigational Site, Cleveland

45406

GSK Investigational Site, Dayton

45431

GSK Investigational Site, Beavercreek

54449

GSK Investigational Site, Marshfield

63141

GSK Investigational Site, St Louis

66480

GSK Investigational Site, San Nicolás de los Garza

66604

GSK Investigational Site, Topeka

67010

GSK Investigational Site, Augusta

67114

GSK Investigational Site, Newton

67207

GSK Investigational Site, Wichita

68504

GSK Investigational Site, Lincoln

68505

GSK Investigational Site, Lincoln

68516

GSK Investigational Site, Lincoln

70006

GSK Investigational Site, Metairie

71111

GSK Investigational Site, Bossier City

72401

GSK Investigational Site, Jonesboro

76135

GSK Investigational Site, Fort Worth

77375

GSK Investigational Site, Tomball

78705

GSK Investigational Site, Austin

80920

GSK Investigational Site, Colorado Springs

80922

GSK Investigational Site, Colorado Springs

83686

GSK Investigational Site, Nampa

84041

GSK Investigational Site, Layton

84057

GSK Investigational Site, Orem

84067

GSK Investigational Site, Roy

84095

GSK Investigational Site, South Jordan

84124

GSK Investigational Site, Salt Lake City

84604

GSK Investigational Site, Provo

84651

GSK Investigational Site, Payson

85741

GSK Investigational Site, Tucson

89104

GSK Investigational Site, Las Vegas

90723

GSK Investigational Site, Paramount

91710

GSK Investigational Site, Chino

91790

GSK Investigational Site, West Covina

92804

GSK Investigational Site, Anaheim

93726

GSK Investigational Site, Fresno

94015

GSK Investigational Site, Daly City

94545

GSK Investigational Site, Hayward

94588

GSK Investigational Site, Pleasanton

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

95051

GSK Investigational Site, Santa Clara

95815

GSK Investigational Site, Sacramento

95822

GSK Investigational Site, Sacramento

95823

GSK Investigational Site, Sacramento

98926

GSK Investigational Site, Ellensburg

01801

GSK Investigational Site, Woburn

77555-1119

GSK Investigational Site, Galveston

04530

GSK Investigational Site, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02242643 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age | Biotech Hunter | Biotech Hunter