Protocol Summary for 108988
| Protocol Id: | 108988 |
| Secondary Ids: |
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| Title: | Administration of a challenge dose of hepatitis B vaccine in subjects who previously received Engerix™-B vaccine. |
| 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: | To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago. This protocol posting deals with objectives & outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. |
| Detailed Description: | |
| Record Verification Date: | March 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | November 2007 |
| Study Completion Date: | May 2008 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | May 2008 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Non-randomized |
| Masking: | Open Label |
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| Masked Investigator: | |
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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: | 17 Year |
| Maximum Age: | 22 Year |
| Enrollment: | 144 |
| 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: |
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information
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Click to view inclusion/exclusion criteria