Last updated: 11/04/2018 05:41:45
Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
GSK study ID
BACDU-001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An exploratory study in healthy elderly subjects to collect urine for the development of assays to detect Streptococcus pneumoniae.
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Positive or negative result using Binax NOW S. pneumoniae Test
Timeframe: within one day
Secondary outcomes:
Positive or negative result using the test to be developed for typing of S. pneumoniae
Timeframe: within one day
Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)
Timeframe: within one day
Interventions:
Procedure/surgery: Urine sample collection
Enrollment:
50
Observational study model:
Cohort
Primary completion date:
2007-30-09
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Streptococcal
Product
Compound N/A
Collaborators
Not applicable
Study date(s)
September 2007 to September 2007
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2007-30-09
Actual study completion date
2007-30-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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