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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by King Saud University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00843895
First Posted: February 13, 2009
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
King Saud University
  Purpose
The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.

Condition Intervention
Pneumococcal Disease Biological: pneumococcal conjugate vaccine(prevenar)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Serotyping of Pneumococci

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Incidence and serotypes of invasive pneumococcal dis. [ Time Frame: 6-8 months ]

Secondary Outcome Measures:
  • Antibiotic susceptibility [ Time Frame: 6-8 months ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: pneumococcal conjugate vaccine(prevenar)
    to see the vaccine impact on pneumococcal diseases
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age less than 5 years

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843895


Contacts
Contact: Atef M. Shibl, PH D 00966505 30 2775 amshibl@ksu.edu.sa

Sponsors and Collaborators
King Saud University
  More Information

Responsible Party: King saud university, wyeth
ClinicalTrials.gov Identifier: NCT00843895     History of Changes
Other Study ID Numbers: kingsadu
First Submitted: February 9, 2009
First Posted: February 13, 2009
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by King Saud University:
Laboratory based study
antibiotic susceptibilty
invasive strains

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs