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Protocol Summary for 112115

Protocol Summary
Protocol Id: 112115
Secondary Ids:
  • N/A
Title: Comparison of the immunogenicity and safety of various investigational and licensed formulations of Hepatitis B surface antigen (HBsAg) vaccines.
Phase: phase 2
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Germany: Paul-Ehrlich-Institut
  • Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Collaborators:
  • N/A
Brief Summary: The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by each of the Adjuvant System. This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria
Detailed Description:
Record Verification Date: December 2012
Status: Completed
Why Study Stopped:
Study Start Date: December 2008
Study Completion Date: July 2011
Study Completion Date Type: Actual
Primary Completion Date: July 2011
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:
  • Cellular immune response to components of the investigational vaccine. 14 days post dose 2 (Day 44)
Secondary Outcomes:
  • Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms for all subjects. During a 14-day follow up period after each vaccine dose.
  • Occurrence, intensity and relationship to booster vaccination of unsolicited local and general signs and symptoms for the subjects belonging to subsets. During a 31-day follow up period.
  • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms for all subjects. During a 31-day follow up period after each vaccine dose.
  • Occurrence, intensity and relationship to booster vaccination of any solicited local and general signs and symptoms for the subjects belonging to subsets. During a 7-day follow up period.
  • Occurrence and relationship to vaccination of all serious adverse events (SAEs) and adverse events of specific interest including AID for all subjects. Throughout the entire study period.
  • Cellular and humoral immune response to components of the investigational vaccine at protocol-defined timepoints. Defined time points in function of the measured parameter
  • Hematological and biochemical levels. At days 0, 30, 37, 60 (M2), 180 (M6), 360 (M12) for all subjects and at day 390 (M13) for the subjects in the subsets.
Conditions:
  • Hepatitis B Vaccine
Keywords:
  • Adjuvant Systems
  • Hepatitis B
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 45 Year
Enrollment: 713
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: GSK Clinical Disclosure
Location and Contact Information: Click to view location information