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.

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

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Procedure: Urine sample collection

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Residents of Belgium and Finland

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): September 1, 2007

Study Registration Dates

• First Submitted: August 30, 2007
• First Submitted That Met QC Criteria: August 30, 2007
• First Posted (ESTIMATE): August 31, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pneumonia; Invasive Pneumococcal Diseases
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pneumonia; Streptococcal Infections
• Other Study ID Numbers: BACDU-001