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

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ClinicalTrials.gov Identifier: NCT00843895
Recruitment Status : Unknown
Verified February 2009 by King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Pneumococcal Disease Biological: pneumococcal conjugate vaccine(prevenar)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Serotyping of Pneumococci
Study Start Date : March 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: pneumococcal conjugate vaccine(prevenar)
    to see the vaccine impact on pneumococcal diseases

Outcome Measures

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

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

Eligibility Criteria

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 Posted: February 13, 2009    Key Record Dates
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