Protocol Summary for 110071
| Protocol Id: | 110071 |
| Secondary Ids: |
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| Title: | Immune response to a hepatitis B vaccine challenge dose in healthy subjects who received primary vaccination of GlaxoSmithKline Biologicals' hepatitis B vaccine, approximately 20 years ago. |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| Brief Summary: | In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose. |
| Detailed Description: | |
| Record Verification Date: | April 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2008 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | August 2008 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Non-randomized |
| Masking: | Open Label |
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| Study Design (Assignment): | Single Group Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | |
| Maximum Age: | |
| Enrollment: | 29 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| 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