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

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ClinicalTrials.gov Identifier: NCT00523770
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Infections, Streptococcal Procedure: Urine sample collection

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
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.
Study Start Date : September 2007
Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Positive or negative result using Binax NOW S. pneumoniae Test [ Time Frame: within one day ]

Secondary Outcome Measures :
  1. Positive or negative result using the test to be developed for typing of S. pneumoniae [ Time Frame: within one day ]
  2. Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi) [ Time Frame: within one day ]

Biospecimen Retention:   Samples With DNA
Urine sample

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523770


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00523770     History of Changes
Other Study ID Numbers: BACDU-001
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by GlaxoSmithKline:
Invasive Pneumococcal Diseases
Pneumonia

Additional relevant MeSH terms:
Pneumonia
Streptococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections