NCT01711736View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

November 1, 2012

Primary Completion Date

February 21, 2013

Study Completion Date

June 19, 2013

Conditions
Influenza
Interventions
BIOLOGICAL

Quadrivalent influenza GSK2282512A vaccine

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

BIOLOGICAL

Fluarix

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Trial Locations (8)

11201

GSK Investigational Site, Santo Domingo, Distrito Nacional

21102

GSK Investigational Site, San Pedro Sula

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

J7J 2K8

GSK Investigational Site, Mirabel

G1E 7G9

GSK Investigational Site, Québec

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01711736 - Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age | Biotech Hunter | Biotech Hunter