Generation of Standard Laboratory Values for Pneumococci Antibodies

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00567632
First received: December 4, 2007
Last updated: January 14, 2011
Last verified: October 2007

December 4, 2007
January 14, 2011
October 2006
October 2010   (final data collection date for primary outcome measure)
sufficient samples to calculate reference values [ Time Frame: 10(2006-10/2007) ] [ Designated as safety issue: No ]
sufficient samples to calculate reference values [ Time Frame: 10(2006-10/2007 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00567632 on ClinicalTrials.gov Archive Site
sufficient samples to correlate with screening assay [ Time Frame: 10/2006-10/2007 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Generation of Standard Laboratory Values for Pneumococci Antibodies
Generation of Standard Laboratory Values for Pneumococci Antibodies

The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

human serum

Non-Probability Sample

any clinically and immunologically healthy subject of any age undergoing selective surgery

Reference Values
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects undergoing elective surgery

Exclusion Criteria:

  • Chronic illness condition,
  • Immunodeficiency
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00567632
1-Rose
Yes
Markus A. Rose, ass. Professor of Paediatrics, Goethe University, Childrens' Hospital
Johann Wolfgang Goethe University Hospitals
Not Provided
Study Chair: Markus A Rose, M.D., Ph.D., M.P.H Goethe University, childrens Hospital
Johann Wolfgang Goethe University Hospitals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP