Status:

COMPLETED

Pneumoniae Epidemiology Study in China

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Pneumococcal Disease

Eligibility:

All Genders

Up to 60 years

Brief Summary

To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

Detailed Description

Subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology...

Eligibility Criteria

Inclusion

  • Age, 60 months or less
  • Meets study criteria for clinical pneumonia
  • All the examination are/can be done within (before or after) 72 hours to enrollment time
  • Informed consent obtained from parent or guardian

Exclusion

  • Received any pneumococcal vaccine in the past
  • Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
  • Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
  • Children with recurrent pneumonia will enter into the study on only one occasion

Key Trial Info

Start Date :

February 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2008

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00471770

Start Date

February 1 2007

End Date

February 1 2008

Last Update

March 13 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tianjin, China, 300074