Protocol Summary for 208141/015
| Protocol Id: | 208141/015 |
| Secondary Ids: |
|
| Title: | Study to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control |
| Phase: | phase 1/2 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
| Oversight Authority: |
|
| Collaborators: |
|
| Brief Summary: | The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control. |
| Detailed Description: | At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham. |
| Record Verification Date: | July 2010 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | August 1995 |
| Study Completion Date: | January 1997 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | January 1997 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | false |
| Masked Caregiver: | false |
| Masked Investigator: | false |
| Masked Assessor: | false |
| 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: | 18 Year |
| Maximum Age: | 45 Year |
| Enrollment: | 130 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | +44 (0) 20 8990 4466 |
| Backup Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| 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