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Protocol Summary for 100409

Protocol Summary
Protocol Id: 100409
Secondary Ids:
  • 100464
  • 100463
Title: A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects
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:
  • Belgium: Institutional Review Board
Collaborators:
  • N/A
Brief Summary: As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.
Detailed Description: Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice. 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: January 2004
Study Completion Date: March 2007
Study Completion Date Type: Actual
Primary Completion Date: March 2007
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms. During a 30-day follow up period after each vaccine dose.
  • Anti-PhtD antibody concentration. One month after 2 injections
  • Occurrence of all serious adverse events (SAE). During the entire study period.
  • Occurrence, intensity and relationship of any solicited local and general signs and symptoms. During a 7-day follow up period after each vaccine dose.
  • Anti- PhtD antibody concentration One month after the first injection
Secondary Outcomes:
  • Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes At month 0, 1 and 12.
  • Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A. At month 0 and 1.
  • Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals. At month 0, 1 and 3.
  • Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects. At month 0, 1, 3, 12.
  • Anti-PhtD antibody avidity. At month 0, 1 and 3.
  • Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects. At month 0 and month 1.
  • Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects. At month 0, 1, 3, 12.
  • Anti-PS antibody avidity for 5 serotypes in Group A. At month 0 and 1.
  • Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes At month 0, 1, 12, 24 and 36.
  • Anti- PhtD antibody concentration. At 12, 24 and 36 months after the first vaccination.
  • Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis. At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Conditions:
  • Streptococcus pneumoniae Vaccines
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 65 Year
Maximum Age:
Enrollment: 146
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