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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00523770

Enrollment

Registered

2007-08-31

Start date

2007-09-30

Completion date

Unknown

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Streptococcal

Keywords

Invasive Pneumococcal Diseases, Pneumonia

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

Interventions

PROCEDUREUrine sample collection

Urine samples will be collected and tested for the presence of S. pneumoniae

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Positive or negative result using Binax NOW S. pneumoniae Test	within one day

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026