Protocol Summary for 711866/003
| Protocol Id: | 711866/003 |
| Secondary Ids: |
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| Title: | Assess immunogenicity, reactogenicity of GSK Biologicals’-dTpa-IPV vaccine versus dTpa & IPV vaccines administered separately & compared with Aventis Pasteur MSD’s Td-IPV vaccine when administered to healthy adolescents & adults |
| Phase: | phase 3 |
| 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 study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals’ reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis® |
| Detailed Description: | |
| Record Verification Date: | January 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | January 2002 |
| Study Completion Date: | April 2002 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | April 2002 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 15 Year |
| Maximum Age: | |
| Enrollment: | 806 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| 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