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OpenTrials
Completed

NCT Number: NCT00523770

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

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

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine sample collection

Procedure

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

Primary outcomes

  1. Positive or negative result using Binax NOW S. pneumoniae Test

    Time frame: within one day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
First posted
Aug 31, 2007
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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