Exploratory Study in Healthy Elderly Subjects to Collect... | NCT00523770

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

NCT00523770

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Infections, Streptococcal

Interventions

Urine sample collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Not provided

First Submitted Date

Aug 30, 2007

First Submission Date that Met QC Criteria

Aug 30, 2007

First Posted Date

Aug 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Non-pneumococcal infected healthy elderly volunteers	Procedure: Urine sample collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urine sample collection	Procedure	Urine samples will be collected and tested for the presence of S. pneumoniae	Group A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Residents of Belgium and Finland

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D013290	Streptococcal Infections
D011014	Pneumonia

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided