Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

PHASE2CompletedINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

September 30, 1998

Primary Completion Date

September 30, 1999

Study Completion Date

September 30, 1999

Conditions
Hepatitis BDiphtheriaHaemophilus Influenzae Type b (Hib)PoliomyelitisPertussisTetanus
Interventions
BIOLOGICAL

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

BIOLOGICAL

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

BIOLOGICAL

HBV (Engerix™-B)

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY