NCT02072525

A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays

A Protocol to Collect Human Serum Samples From Healthy Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Menveo®	One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
BIOLOGICAL	Boostrix®	One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
BIOLOGICAL	Pneumovax 23®	One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
BIOLOGICAL	Prevnar 13®	One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-02
• Completion: 2015-06-02
• First posted: 2014-02-26
• Last updated: 2017-11-27

Locations

1 site across 1 country: Canada