Protocol Summary for 106316
| Protocol Id: | 106316 |
| Secondary Ids: |
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| Title: | A study to evaluate immunogenicity and safety of Boostrix compared to Adacel when administered as a booster vaccination in adults aged 19 to 64 years of age |
| Phase: | phase 3 |
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| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CBER |
| IND/IDE Number: | BB-IND-8461 |
| IND/IDE Serial Number: | NA |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | GSK Biologicals’ dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age. |
| Detailed Description: | |
| Record Verification Date: | August 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2007 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | March 2007 |
| 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 |
| Primary Outcomes: |
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| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 19 Year |
| Maximum Age: | 64 Year |
| Enrollment: | 2337 |
| Enrollment Type: | Actual |
| 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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