Protocol Summary for 110080
| Protocol Id: | 110080 |
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| Title: | A phase IIIb, controlled, multicenter study to evaluate antibody persistence at 1, 3, 5 and 10 years following administration of a single dose of Tdap vaccine to healthy subjects, 19 years of age and older in the study 106316 |
| Phase: | phase 3 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| 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: | This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3, 5 and 10. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00346073). This study will provide information regarding the persistence of antibodies to diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens, up to 10 years following vaccination with GSK Bio's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed. |
| Detailed Description: | Open, multicenter study with the same two parallel groups as in the primary study (NCT00346073). No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination. Subjects were randomized (2:1 ratio) in the primary study and will not be further randomized during this persistence phase. This protocol posting is updated in order to comply with the FDA AA, Sep 2007. |
| Record Verification Date: | September 2012 |
| Status: | Active not recruiting |
| Why Study Stopped: | |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2016 |
| Study Completion Date Type: | Anticipated |
| Primary Completion Date: | September 2007 |
| 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: | 20 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 1592 |
| 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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