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Protocol Summary for 111652

Protocol Summary
Protocol Id: 111652
Secondary Ids:
  • N/A
Title: A study to evaluate GSK Biologicals’ candidate formulations of pneumococcal vaccines (GSK2189241A) in elderly subjects.
Phase: phase 1
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Sweden: Medical Products Agency
Collaborators:
  • N/A
Brief Summary: The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.
Detailed Description:
Record Verification Date: March 2009
Status: Completed
Why Study Stopped:
Study Start Date: September 2008
Study Completion Date: May 2009
Study Completion Date Type: Actual
Primary Completion Date: May 2009
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: yes
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety Study
Primary Outcomes:
  • Occurrence of any vaccine related and grade 3 solicited local and general adverse events no During a 7-day follow up period after each vaccine dose
  • Occurrence of any vaccine related and grade 3 unsolicited adverse events no During a 31-day follow up period after each vaccine dose
  • Occurrence of any vaccine related serious adverse events (SAE) no From dose 1 to study conclusion
  • Occurrence of any grade 3 laboratory abnormalities no At 1 and 7 days after each vaccine dose
Secondary Outcomes:
  • Occurrence of any solicited local and general adverse events no During a 7-day follow up period after each vaccine dose
  • Occurrence of any unsolicited adverse events no During a 31-day follow up period after each vaccine dose
  • Occurrence of any laboratory abnormalities no At 1 and 7 days after each vaccine dose
  • Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity no From dose 1 to study conclusion
  • Anti-pneumococcal and anti-NTHi candidate vaccine antigens no At Days 0, 30 and 90
Conditions:
  • Streptococcus pneumoniae Vaccines
Keywords:
  • Streptococcus pneumoniae
  • pneumococcal vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 65 Year
Maximum Age: 85 Year
Enrollment: 168
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