Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

April 21, 2004

Primary Completion Date

January 10, 2008

Study Completion Date

January 10, 2008

Conditions
Hepatitis B
Interventions
BIOLOGICAL

Engerix™-B (thiomersal-free) 20µg

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

BIOLOGICAL

10 μg Engerix™-B (preservative-free)

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

BIOLOGICAL

placebo

In the primary study: 1 deep intramuscular injection (month 1)

Trial Locations (4)

1200

GSK Investigational Site, Brussels

2610

GSK Investigational Site, Wilrijk

Unknown

GSK Investigational Site, Sydney

03038

GSK Investigational Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00343915 - Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs | Biotech Hunter | Biotech Hunter