drugset / Trial / NCT00697866

Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

NCT00697866

Phase 3 Completed 951 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.

Timeline

Start
2000-08
Primary completion
2001-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine Intramuscular
Subject HBV-MPL vaccine 208129 Vaccine Intramuscular