Protocol Summary for 208129/037
| Protocol Id: | 208129/037 |
| Secondary Ids: |
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| Title: | Evaluating the consistency of 3 consecutive lots of GSK Bio's novel adjuvanted HBV vaccine with single-blind safety evaluation using Engerix™-B as a control, administered according to a 0, 1, 2-mth schedule in healthy volunteers (15-50y). |
| 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 the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control. |
| Detailed Description: | Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham |
| Record Verification Date: | November 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | August 2000 |
| Study Completion Date: | |
| Study Completion Date Type: | None |
| Primary Completion Date: | February 2001 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | Prevention |
| Allocation: | Randomized |
| Masking: | Single Blind |
| Masked Subject: | true |
| 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: | 15 Years |
| Maximum Age: | 50 Years |
| Enrollment: | 951 |
| 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