At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 667 enrolled
Drug / intervention
Engerix™-B vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Assess the Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine, Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
In Brief
A Phase 4 clinical trial evaluating Engerix™-B vaccine for Hepatitis B. Completed, enrolled 667 participants across 22 sites in 4 countries.
Detailed Summary
This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesAustralia, Canada, New Zealand, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedJun 25, 2012
Enrollment StartJul 24, 2012
Primary CompletionDec 18, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.0 years ago
Interventions
Engerix™-B vaccinebiological
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.