Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

October 23, 2013

Primary Completion Date

February 27, 2014

Study Completion Date

July 3, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

FluLaval® Quadrivalent

1 or 2 doses administered intramuscularly (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®

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 (12)

13210

GSK Investigational Site, Syracuse

16148

GSK Investigational Site, Hermitage

29520

GSK Investigational Site, Cheraw

29812

GSK Investigational Site, Barnwell

32701

GSK Investigational Site, Altamonte Springs

44121

GSK Investigational Site, Cleveland

49127

GSK Investigational Site, Stevensville

76135

GSK Investigational Site, Fort Worth

91790

GSK Investigational Site, West Covina

95822

GSK Investigational Site, Sacramento

02721

GSK Investigational Site, Fall River

01801

GSK Investigational Site, Woburn

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY