Meningococcal Clinical Trial
Official title:
A Protocol to Collect Human Serum Samples From Healthy Adults
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02867319 -
Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
|
Phase 1 | |
| Active, not recruiting |
NCT03746665 -
Maternal Immunization With MenAfriVac™
|
Phase 3 |