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Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years (Pneumococci)

Primary Purpose

Pneumococcal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pneumococcal conjugate vaccine(prevenar)
Sponsored by
King Saud University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Pneumococcal Disease focused on measuring Laboratory based study, antibiotic susceptibilty, invasive strains

Eligibility Criteria

3 Weeks - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age less than 5 years

Exclusion Criteria:

  • none

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence and serotypes of invasive pneumococcal dis.

    Secondary Outcome Measures

    Antibiotic susceptibility

    Full Information

    First Posted
    February 9, 2009
    Last Updated
    February 11, 2009
    Sponsor
    King Saud University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00843895
    Brief Title
    Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years
    Acronym
    Pneumococci
    Official Title
    Serotyping of Pneumococci
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    August 2009 (Anticipated)
    Study Completion Date
    December 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    King Saud University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumococcal Disease
    Keywords
    Laboratory based study, antibiotic susceptibilty, invasive strains

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    pneumococcal conjugate vaccine(prevenar)
    Intervention Description
    to see the vaccine impact on pneumococcal diseases
    Primary Outcome Measure Information:
    Title
    Incidence and serotypes of invasive pneumococcal dis.
    Time Frame
    6-8 months
    Secondary Outcome Measure Information:
    Title
    Antibiotic susceptibility
    Time Frame
    6-8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Weeks
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age less than 5 years Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Atef M. Shibl, PH D
    Phone
    00966505 30 2775
    Email
    amshibl@ksu.edu.sa

    12. IPD Sharing Statement

    Learn more about this trial

    Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years

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