Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae

This study has been completed.
Sponsor:
Collaborator:
National Institute for Health and Welfare, Finland
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00523770
First received: August 30, 2007
Last updated: September 2, 2008
Last verified: September 2008

August 30, 2007
September 2, 2008
September 2007
September 2007   (final data collection date for primary outcome measure)
Positive or negative result using Binax NOW S. pneumoniae Test
Not Provided
Complete list of historical versions of study NCT00523770 on ClinicalTrials.gov Archive Site
  • Positive or negative result using the test to be developed for typing of S. pneumoniae
  • Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)
Not Provided
Not Provided
Not Provided
 
Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.

GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

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

Urine sample

Probability Sample

Residents of Belgium and Finland

  • Pneumonia,
  • Invasive Pneumococcal Diseases
Procedure: Urine sample collection
Urine samples will be collected and tested for the presence of S. pneumoniae
Group A
Non-pneumococcal infected healthy elderly volunteers
Intervention: Procedure: Urine sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 65 and 85 years of age at the time of the study.
  • Written informed consent obtained from the subject
  • Healthy subjects as established by medical history and clinical examination before entering into the study

Exclusion Criteria:

  • Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,
  • History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00523770
BACDU-001
Not Provided
Isabelle Harpigny, GSK
GlaxoSmithKline
National Institute for Health and Welfare, Finland
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2008

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