Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

January 31, 2001

Primary Completion Date

November 30, 2002

Study Completion Date

November 30, 2002

Conditions
Hepatitis B
Interventions
BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

BIOLOGICAL

DTPa-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

BIOLOGICAL

EngerixTM-B

The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY