Protocol Summary for 208129/036
| Protocol Id: | 208129/036 |
| Secondary Ids: |
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| Title: | Study to compare the immunogenicity and safety of GSK Biologicals’ novel adjuvanted HBV vaccine (0, 21-day schedule) to a double dose of Engerix™ -B (0, 7, 21-day schedule), in pre-liver transplant patients ≥ 18 y, boosted at month 6-12 |
| Phase: | Phase 3 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | No |
| Study Type: | Interventional |
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| Brief Summary: | The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine |
| Detailed Description: | At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham |
| Record Verification Date: | September 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | January 2000 |
| Study Completion Date: | |
| Study Completion Date Type: | None |
| Primary Completion Date: | May 2002 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | Prevention |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | false |
| Masked Caregiver: | false |
| Masked Investigator: | false |
| Masked Assessor: | false |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Keywords: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Years |
| Maximum Age: | N/A |
| Enrollment: | 93 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | No |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | +44 (0) 20 8990 4466 |
| Backup Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria