Protocol Summary for 106640
| Protocol Id: | 106640 |
| Secondary Ids: |
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| Title: | Evaluate the anti-HBs antibody persistence, in subjects who received GSK Biologicals’ preservative-free or thiomersal-free Engerix™-B or Engerix™-B containing thiomersal, approximately 5 to 6 yrs earlier |
| Phase: | Phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | No |
| Study Type: | Observational |
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| Brief Summary: | To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study. |
| Detailed Description: | All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study. |
| Record Verification Date: | September 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | May 2006 |
| Study Completion Date: | |
| Study Completion Date Type: | None |
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| Study Design: | |
| Time Perspective: | Prospective Study |
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| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Years |
| Maximum Age: | 50 Years |
| Enrollment: | 632 |
| Enrollment Type: | |
| 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: |
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