NCT00567632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 17, 2011

Status Verified

October 1, 2007

Enrollment Period

4 years

First QC Date

December 4, 2007

Last Update Submit

January 14, 2011

Conditions

Reference Values

Keywords

PneumococciAntibodyStandard laboratory values

Outcome Measures

Primary Outcomes (1)

  • sufficient samples to calculate reference values

    10(2006-10/2007)

Secondary Outcomes (1)

  • sufficient samples to correlate with screening assay

    10/2006-10/2007

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects undergoing elective surgery

You may not qualify if:

  • Chronic illness condition,
  • Immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

human serum

Study Officials

  • Markus A Rose, M.D., Ph.D., M.P.H

    Goethe University, childrens Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

October 1, 2006

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

January 17, 2011

Record last verified: 2007-10

Locations

DE(1)