Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

745

Participants

Timeline

Start Date

February 10, 2005

Primary Completion Date

March 1, 2006

Study Completion Date

March 10, 2006

Conditions
Whole Cell PertussisDiphtheriaHepatitis BTetanusHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

Tritanrix™-HepB/Hiberix™ Kft.

GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.

BIOLOGICAL

Tritanrix™-HepB/Hiberix™

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

BIOLOGICAL

Hiberix™

GSK Biologicals' Haemophilus influenzae type b vaccine

BIOLOGICAL

Polyribosil-Ribitol-Phosphate (PRP) vaccine

plain PRP polysaccharide vaccine

BIOLOGICAL

Tritanrix™-HepB Kft

GSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.

Trial Locations (3)

1109

GSK Investigational Site, Quezon City

1781

GSK Investigational Site, City of Muntinlupa

Unknown

GSK Investigational Site, Pasay

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY