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Protocol Summary for 112691

Protocol Summary
Protocol Id: 112691
Secondary Ids:
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
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
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:
  • Humoral immune response in terms of H5N1 HI antibody titers At Day 42
  • Humoral immune response in terms of H5N1 hemagglutination inhibition (HI) antibody titers At Day 0
Secondary Outcomes:
  • Occurrence of unsolicited adverse events (AE) During a 21-day (Day 0 to Day 20) follow-up period after each vaccination and overall up to Day 84
  • Occurrence of AEs with medically attended visits During the entire study period (Day 0 to Day 385)
  • Humoral immune response in terms of H5N1 HI antibody titers At Day 0, Day 42 and Day 182
  • Occurrence of solicited local and general symptoms During a 7-day follow-up period after each vaccination
  • Number of subjects with clinical safety laboratory abnormalities At Day 0 and Day 42
  • Occurrence of potential immune-mediated diseases During the entire study period (Day 0 to Day 385)
  • Occurrence of serious adverse events During the entire study period (Day 0 to Day 385)
Conditions:
  • Influenza infection
Keywords:
  • H5N1
  • Influenza vaccine
  • influenza infection
  • GSK1557484A
Eligibility Criteria: Click to view inclusion/exclusion 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.