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 because the information has not been verified recently.
Verified February 2009 by King Saud University.
Recruitment status was  Not yet recruiting
Information provided by:
King Saud University Identifier:
First received: February 9, 2009
Last updated: February 11, 2009
Last verified: February 2009
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 Blind (Subject)
Primary Purpose: Screening
Official Title: Serotyping of Pneumococci

Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Incidence and serotypes of invasive pneumococcal dis. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibiotic susceptibility [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age less than 5 years

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00843895

Contact: Atef M. Shibl, PH D 00966505 30 2775

Sponsors and Collaborators
King Saud University
  More Information

Responsible Party: King saud university, wyeth Identifier: NCT00843895     History of Changes
Other Study ID Numbers: kingsadu 
Study First Received: February 9, 2009
Last Updated: February 11, 2009
Health Authority: Saudi Arabia: Research Advisory Council

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

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016