Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan

NCT00757575

Last updated date
Study Location
Kushiro, Hokkaido, 085-0032, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-60

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Advanced Information
Descriptive Information
Brief Title Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
Official Title Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan
Brief Summary Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido Currently, only a limited information about pneumococcal disease burden is available in Japan.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.
Condition Pneumococcal Disease
Intervention Not Provided
Study Groups/Cohorts 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2012)
28511
Original Estimated Enrollment
 (submitted: September 22, 2008)
10000
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Eligibility Criteria

- Children residing in the surveillance area(s) aged 28 days to <60 months with clinical suspicion of pneumonia, meningitis and bacteremia who were admitted to the hospital.

Sex/Gender
Sexes Eligible for Study:All
Ages up to 60 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00757575
Other Study ID Numbers 0887X1-4424
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date March 2012