drugset / Trial / NCT00383591

Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

NCT00383591 ↗

Phase 3 Completed 120 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres \< 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

Timeline

Start
2002-03
Primary completion
—
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Engerix-B Vaccine — —
Subject Hepatitis B adjuvanted vaccine Vaccine — —