Protocol Summary for 104387
| Protocol Id: | 104387 |
| Secondary Ids: |
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| Title: | Demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, multidose Engerix™-B to that of monodose Engerix™-B when administered according to 0,1,6 mths schedule in healthy adults aged ≥ 18 yrs |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| Brief Summary: | GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium). |
| Detailed Description: | Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine |
| Record Verification Date: | February 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | March 2005 |
| Study Completion Date: | December 2005 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | December 2005 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Single Blind |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion criteria:
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| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | |
| Enrollment: | 280 |
| Enrollment Type: | |
| Healthy Volunteers?: | yes |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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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: |
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information
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Click to view inclusion/exclusion criteria