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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
History of Changes
  Purpose

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


Condition Intervention
Pneumonia,
Invasive Pneumococcal Diseases
 Procedure: Urine sample collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Positive or negative result using Binax NOW S. pneumoniae Test

Secondary Outcome Measures:
  • 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)

Biospecimen Retention:   Samples Without DNA

Urine sample


Enrollment: 50
Study Start Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Non-pneumococcal infected healthy elderly volunteers
 Procedure: Urine sample collection
Urine samples will be collected and tested for the presence of S. pneumoniae

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Residents of Belgium and Finland

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523770

Locations
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
GlaxoSmithKline
National Institute for Health and Welfare, Finland
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00523770     History of Changes
Other Study ID Numbers: BACDU-001
Study First Received: August 30, 2007
Last Updated: September 2, 2008
Health Authority: Belgium:Ghent

Keywords provided by GlaxoSmithKline:
Pneumonia,
Invasive Pneumococcal Diseases

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013