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Protocol Summary for 208141/042

Protocol Summary
Protocol Id: 208141/042
Secondary Ids:
  • N/A
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
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
  • N/A
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:
  • Anti-gD antibody titre in the entire cohort (10–17 yrs) no At month 7
Secondary Outcomes:
  • Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity yes Throughout the study
  • Occurrence and relationship to vaccination of SAEs yes Throughout the study period
  • Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039 no At month 7
  • Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039 no At month 7
  • In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects no At months 0, 2, 7, and 12
  • Anti-gD antibody titre no At months 2 and 12
  • Anti-HSV neutralizing antibodies no At months 2, 7 and 12
  • Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated. yes Within 7 days after each vaccination
  • Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms yes Within 7 days after each vaccination
  • Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events yes Within 30 days after any vaccination
Conditions:
  • Herpes Simplex
Keywords:
  • Herpes Simplex vaccine
  • Immunogenicity
  • Safety
  • Adolescents
Eligibility Criteria: Click to view inclusion/exclusion 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: Click to view location information