Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

January 31, 2004

Study Completion Date

August 31, 2004

Conditions
Haemophilus Influenzae Type b
Interventions
BIOLOGICAL

Tritanrix™-HepB low thio /

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Hib 2.5

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Tritanrix™-HepB

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Hiberix™

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Unconjugated Hib vaccine (plain PRP)

One dose as intramuscular injection at 10 months of age

Trial Locations (1)

1781

GSK Investigational Site, City of Muntinlupa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY