drugset / Trial / NCT00197184

Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

NCT00197184

Phase 3 Completed 276 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start
2003-11-01
Primary completion
2004-03-10
Completion
2004-03-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator TWINRIX™ ADULT Vaccine Intramuscular
Subject Twinrix™ Junior Vaccine Intramuscular