Protocol Summary for 112691
| Protocol Id: | 112691 |
| Secondary Ids: |
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| Title: | Immunogenicity and safety study of GSK Biologicals’ monovalent pandemic H5N1 vaccine 1557484A in adults aged 18 – 64 years |
| Phase: | phase 2 |
| 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 13413 |
| IND/IDE Serial Number: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | This trial will assess the immunogenicity and safety of GSK Biologicals’ vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production. |
| Detailed Description: | |
| Record Verification Date: | December 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | August 2011 |
| Study Completion Date: | November 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | November 2011 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | N\A |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Single Group 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: | 18 Year |
| Maximum Age: | 64 Year |
| Enrollment: | 78 |
| 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: | GlaxoSmithKline |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria