Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

PHASE4CompletedINTERVENTIONAL
Enrollment

494

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

May 31, 2005

Study Completion Date

May 31, 2005

Conditions
Hepatitis BPoliomyelitisDiphtheriaAcellular PertussisTetanusHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)

Three doses administered intramuscularly

BIOLOGICAL

DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)

Three doses administered intramuscularly

Trial Locations (9)

27100

GSK Investigational Site, Pavia

40138

GSK Investigational Site, Bologna

70124

GSK Investigational Site, Bari

73013

GSK Investigational Site, Galatina (LE)

73024

GSK Investigational Site, Maglie (LE)

00300

GSK Investigational Site, Helsinki

07100

GSK Investigational Site, Sassari

SE-581 85

GSK Investigational Site, Linköping

SE-701 85

GSK Investigational Site, Örebro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01457547 - Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course | Biotech Hunter | Biotech Hunter