850
Participants
Start Date
November 12, 2010
Primary Completion Date
March 28, 2012
Study Completion Date
December 8, 2012
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
GSK Investigational Site, Pantelimon
GSK Investigational Site, Timișoara
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Brasov
GSK Investigational Site, Brasov
GSK Investigational Site, Brasov
GSK Investigational Site, Sibiu
GSK Investigational Site, Bacau
GSK Investigational Site, Iași
GSK Investigational Site, Galati
GSK Investigational Site, Galati
GSK Investigational Site, Galati
GSK Investigational Site, Galati
GSK Investigational Site, Galati
GSK Investigational Site, Brăila
GSK Investigational Site, Brăila
GSK Investigational Site, Constanța
GSK Investigational Site, Constanța
GSK Investigational Site, Călăraşi
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
Lead Sponsor
GlaxoSmithKline
INDUSTRY