Protocol Summary for 208141/042
| Protocol Id: | 208141/042 |
| Secondary Ids: |
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| Title: | Study to Compare Immunogenicity & Safety of 3 comercial Lots of GlaxoSmithKline (GSK) Biologicals’ herpes simplex candidate Vaccine in Healthy HSV-1 & -2 Seronegative (HSV 1-/2-) Females of 10–17 y & Vaccine Immunogenicity in Healthy HSV 1-/2- Females of 10–17 y With Healthy HSV 1-/2- Adult Females |
| 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 5505 |
| IND/IDE Serial Number: | NA |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized. |
| Detailed Description: | At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. |
| Record Verification Date: | September 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | December 2003 |
| Study Completion Date: | January 2006 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | January 2006 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | prevention |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Female |
| Minimum Age: | 10 Year |
| Maximum Age: | 17 Year |
| Enrollment: | 671 |
| 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: |
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Click to view inclusion/exclusion criteria