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NCT01627340 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 667
- Enrollment target
NCT01627340: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01627340 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 667 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01627340, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 667 participants
- Enrollment target
Study 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.
Primary Outcome
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).
Interventions
- BIOLOGICAL Engerix™-B vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2012-07-24 |
| Est. Completion | 2013-12-18 |
| Phase | Phase 4 |
What the finished NCT01627340 record still lists
NCT01627340 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 1 intervention - of which Engerix™-B vaccine is the first listed.
NCT01627340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01627340 about?
NCT01627340 is a clinical study titled "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus". 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.
What is the current status of trial NCT01627340?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 667 participants. The study started on 2012-07-24. Estimated completion is 2013-12-18.
What interventions are being tested in trial NCT01627340?
The interventions under investigation include: Engerix™-B vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01627340?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01627340's enrollment target sits among peer trials
667 120th of 2000 higher than 1,881 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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