Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

June 5, 2014

Primary Completion Date

October 14, 2016

Study Completion Date

October 14, 2016

Conditions
Infections, Meningococcal
Interventions
BIOLOGICAL

Meningococcal group B Vaccine, rMenB+OMV NZ

4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.

BIOLOGICAL

Meningococcal ACWY Conjugate Vaccine, MenACWY

4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.

Trial Locations (7)

58070

GSK Investigational Site, Morelia

C1425DEM

GSK Investigational Site, Buenos Aires

C1425EFD

GSK Investigational Site, Buenos Aires

X5000JRD

GSK Investigational Site, Córdoba

04530

GSK Investigational Site, Mexico City

06400

GSK Investigational Site, Mexico City

06760

GSK Investigational Site, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY