Protocol Summary for 208129/033
| Protocol Id: | 208129/033 |
| Secondary Ids: |
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| Title: | A study to compare the immunogenicity and safety of GSK Biologicals adjuvanted HBV vaccine to Engerix™-B, in a non-responder population ≥ 15 years of age, when administered intramuscularly, according to a 0, 1, 2, 12 month schedule |
| Phase: | phase 3 |
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| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| Brief Summary: | Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B. |
| Detailed Description: | At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham. |
| Record Verification Date: | July 2010 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | November 1999 |
| Study Completion Date: | May 2001 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | September 2000 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Single Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 15 Year |
| Maximum Age: | |
| Enrollment: | 145 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
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| 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