Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
Completed
- Conditions
- Infections, Streptococcal
- Interventions
- Procedure: Urine sample collection
- Registration Number
- NCT00523770
- Lead Sponsor
- GlaxoSmithKline
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A Urine sample collection Non-pneumococcal infected healthy elderly volunteers
- Primary Outcome Measures
Name Time Method Positive or negative result using Binax NOW S. pneumoniae Test within one day
- Secondary Outcome Measures
Name Time Method Positive or negative result using the test to be developed for typing of S. pneumoniae within one day Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi) within one day