drugset / Trial / NCT00289731

Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

NCT00289731

Phase 4 Completed 596 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start
2003-11-24
Primary completion
2004-12-21
Completion
2004-12-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine 20 ug Intramuscular
Comparator HBVAXPRO Vaccine 10 ug Intramuscular
Comparator Havrix Vaccine 1440 unknown Intramuscular
Subject Twinrix Vaccine Intramuscular
Comparator Vaqta Vaccine 50 iu Intramuscular