The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay range.
The purpose of this protocol is to source human serum from plasma from healthy adults for use as control samples in the assays supporting the clinical development of GSK Biologicals' vaccines for the prevention of invasive infections caused by Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis. At the final visit, a small volume of whole blood will be obtained in addition to plasma, to allow for head to head comparison of serum obtained from whole blood (off-clot serum) and from plasma (serum derived from re-calcified plasma). In addition, sera generated in this clinical trial could potentially be used as control samples for other vaccine programs to help assure the quality of the analytical methods. Subjects 18 through 49 years of age (have not yet achieved 50th birthday) will be randomized to receive Menveo + Boostrix and subjects 50 to 55 years of age will be randomized to receive either Pneumovax 23 or Prevnar 13 and will serve as donors of human serum in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
359
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
GSK Investigational Site
Sherbrooke, Quebec, Canada
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Time frame: At Visit 2 (Day 0).
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Time frame: At 10 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Time frame: At 30 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Time frame: At 60 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Time frame: At 120 days post-vaccination
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One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Occurrence of serious adverse events related to vaccination and to lack of vaccine efficacy throughout the study.
Time frame: Throughout the study (Day 0 to Day 30 - Day 180).