Protocol Summary for 110804
| Protocol Id: | 110804 |
| Secondary Ids: |
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| Title: | Evaluation of GSK Bio's dTpa booster vaccine in adults, given 10 years after previous dTpa boosting. |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
| Oversight Authority: |
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| Brief Summary: | The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study. Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. No new recruitment will be performed in this booster phase (see inclusion criteria) |
| Detailed Description: | |
| Record Verification Date: | |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2008 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | April 2008 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Non-randomized |
| Masking: | Open Label |
| Masked Subject: | |
| Masked Caregiver: | |
| Masked Investigator: | |
| Masked Assessor: | |
| 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: | 28 Year |
| Maximum Age: | |
| Enrollment: | 205 |
| 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: |
Click to view location
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Click to view inclusion/exclusion criteria