Protocol Summary for 100406/004
| Protocol Id: | 100406/004 |
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| Title: | A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Biologicals' Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120 |
| 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: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological’s candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments. |
| Detailed Description: | |
| Record Verification Date: | February 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | November 2003 |
| Study Completion Date: | May 2004 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | May 2004 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | yes |
| Masked Investigator: | yes |
| Masked Assessor: | yes |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety Study |
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| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 9 Year |
| Maximum Age: | 13 Year |
| Enrollment: | 321 |
| 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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