Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™

PHASE4CompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 1, 2009

Primary Completion Date

July 1, 2014

Study Completion Date

July 1, 2014

Conditions
Hepatitis BHepatitis A
Interventions
PROCEDURE

Blood sampling

Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.

BIOLOGICAL

Additional challenge dose

If a subject became seronegative for anti-HAV antibodies (\< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.

Trial Locations (2)

1200

GSK Investigational Site, Brussels

500 03

GSK Investigational Site, Hradec Králové

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY