Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

November 12, 2010

Primary Completion Date

March 28, 2012

Study Completion Date

December 8, 2012

Conditions
Infections, Streptococcal
Interventions
BIOLOGICAL

GSK1024850A (SynflorixTM)

Intramuscular injection, 4 doses

BIOLOGICAL

Infanrix hexa

Intramuscular injection, 3 doses

BIOLOGICAL

Infanrix-IPV/Hib

Intramuscular injection, 1 dose

DRUG

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

DRUG

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

Trial Locations (23)

77145

GSK Investigational Site, Pantelimon

300593

GSK Investigational Site, Timișoara

400217

GSK Investigational Site, Cluj-Napoca

500063

GSK Investigational Site, Brasov

500260

GSK Investigational Site, Brasov

500366

GSK Investigational Site, Brasov

550166

GSK Investigational Site, Sibiu

600316

GSK Investigational Site, Bacau

700115

GSK Investigational Site, Iași

800099

GSK Investigational Site, Galati

800179

GSK Investigational Site, Galati

800235

GSK Investigational Site, Galati

800322

GSK Investigational Site, Galati

800394

GSK Investigational Site, Galati

810289

GSK Investigational Site, Brăila

810346

GSK Investigational Site, Brăila

900709

GSK Investigational Site, Constanța

900721

GSK Investigational Site, Constanța

910160

GSK Investigational Site, Călăraşi

030442

GSK Investigational Site, Bucharest

050734

GSK Investigational Site, Bucharest

051821

GSK Investigational Site, Bucharest

077190

GSK Investigational Site, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY