Protocol Summary for 263855/034
| Protocol Id: | 263855/034 |
| Secondary Ids: |
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| Title: | Double-blind, randomized, phase III clinical trial to evaluate the immunogenicity and reactogenicity of three consecutive doses of dTpa, or of dTpa-IPV followed by two doses of Td vaccine , and compared to three consecutive doses of Td vaccine administered to healthy adults in a 0,1,6-month schedule |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| Brief Summary: | This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults. |
| Detailed Description: | |
| Record Verification Date: | February 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | April 2003 |
| Study Completion Date: | September 2004 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | September 2004 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | 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: | 40 Year |
| Maximum Age: | |
| Enrollment: | 460 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | |
| Backup Central Contact Phone: | |
| Backup Central Contact Email: | |
| 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