Trials / Completed
CompletedNCT01627340
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 667 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Engerix™-B vaccine | 3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
Timeline
- Start date
- 2012-07-24
- Primary completion
- 2013-12-18
- Completion
- 2013-12-18
- First posted
- 2012-06-25
- Last updated
- 2018-07-31
- Results posted
- 2015-01-09
Locations
22 sites across 4 countries: United States, Australia, Canada, New Zealand
Source: ClinicalTrials.gov record NCT01627340. Inclusion in this directory is not an endorsement.