Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

August 13, 2009

Primary Completion Date

January 27, 2010

Study Completion Date

January 27, 2010

Conditions
TetanusDiphtheriaHaemophilus Influenzae Type bPoliomyelitisAcellular PertussisHepatitis BDiphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Interventions
BIOLOGICAL

GSK2202083A vaccine

Intramuscular, three doses

BIOLOGICAL

10-valent pneumococcal vaccine (GSK 1024850A)

Intramuscular, three doses

BIOLOGICAL

Infanrix hexa™

Intramuscular, three doses

BIOLOGICAL

Menjugate®

Intramuscular, two doses

Trial Locations (9)

50345

GSK Investigational Site, Wroclaw

85-021

GSK Investigational Site, Bydgoszcz

39-200

GSK Investigational Site, Dębica

31-503

GSK Investigational Site, Krakow

Unknown

GSK Investigational Site, Krakow

GSK Investigational Site, Torun

41-103

GSK Investigational Site, Siemianowice Śląskie

33-100

GSK Investigational Site, Tarnów

55-100

GSK Investigational Site, Trzebnica

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00970307 - Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age | Biotech Hunter | Biotech Hunter