Protocol Summary for 106745
| Protocol Id: | 106745 |
| Secondary Ids: |
|
| Title: | Multicentre study to assess persistence of antibodies against hepatitis B & immune response to a hepatitis B challenge dose in healthy children 4 to 6 yrs old previously vaccinated with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
| Oversight Authority: |
|
| Collaborators: |
|
| Brief Summary: | |
| Detailed Description: | |
| Record Verification Date: | April 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | June 2006 |
| Study Completion Date: | |
| Study Completion Date Type: | |
| Primary Completion Date: | |
| Primary Completion Date Type: | |
| Primary Purpose: | prevention |
| Allocation: | Non-randomized |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
|
| Secondary Outcomes: |
|
| Conditions: |
|
| Keywords: |
|
| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 4 Year |
| Maximum Age: | 6 Year |
| Enrollment: | 300 |
| Enrollment Type: | |
| 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: |
Click to view location
information
|