Pneumoniae Epidemiology Study in China

NCT00471770 | Completed DMC

• 1 other identifier: 0887X-101894
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (1)

• The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

  1 year

Study Arms (3)

1

1.Core group: enrolled subjects who have isolated pneumococcal

2

2.SPN group:enrolled subjects who have no isolated pneumococcal

3

3.DCF group: Subjects screened but not enrolled

Eligibility Criteria

• Age: Up to 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Tianjin, 300074, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

CN (1)