Pneumoniae Epidemiology Study in China

Back to Search
Print
Bookmark Trial

NCT00471770

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Tianjin, , 300074, China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Pneumococcal DiseaseSafety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
NCT04642079
  1. Bristol, Tennessee
  2. Jonesboro, Arkansas
  3. Jonesboro, Arkansas
  4. Inglewood, California
  5. San Diego, California
  6. Miami, Florida
  7. Miami, Florida
  8. Chamblee, Georgia
  9. Sioux City, Iowa
  10. Newton, Kansas
  11. Wichita, Kansas
  12. Bardstown, Kentucky
  13. Lexington, Kentucky
  14. Gulfport, Mississippi
  15. Grand Island, Nebraska
  16. Lincoln, Nebraska
  17. Lincoln, Nebraska
  18. Norfolk, Nebraska
  19. Omaha, Nebraska
  20. Henderson, Nevada
  21. Albuquerque, New Mexico
  22. Binghamton, New York
  23. Dayton, Ohio
  24. Dayton, Ohio
  25. Dayton, Ohio
  26. Medford, Oregon
  27. North Charleston, South Carolina
  28. Bristol, Tennessee
  29. Austin, Texas
  30. Galveston, Texas
  31. San Antonio, Texas
  32. Murray, Utah
  33. Provo, Utah
  34. Salt Lake City, Utah
  35. Salt Lake City, Utah
  36. Salt Lake City, Utah
  37. South Jordan, Utah
  38. Syracuse, Utah
  39. Charlottesville, Virginia
  40. Charlottesville, Virginia
ALL GENDERS
15 Months+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
NCT04546425
  1. Nedlands, Western Australia
  2. Hvidovre,
  3. Roma, Rome
  4. Stavanger,
  5. Poznan,
  6. Poznan,
  7. Westmead, New South Wales
  8. Nedlands, Western Australia
  9. Brussels,
  10. Edegem,
  11. Jindrichuv Hradec,
  12. Jindrichuv Hradec,
  13. Jindrichuv Hradec,
  14. Pardubice,
  15. Praha 3,
  16. Praha 6,
  17. Sezemice,
  18. Tallinn,
  19. Tallinn,
  20. Tallinn,
  21. Tallinn,
  22. Tartu,
  23. Espoo,
  24. Helsinki,
  25. Helsinki,
  26. Järvenpää,
  27. Kokkola,
  28. Oulu,
  29. Pori,
  30. Seinajoki,
  31. Tampere,
  32. Turku,
  33. Milano, Milan
  34. Firenze,
  35. Foggia,
  36. Genova,
  37. Haarlem,
  38. Hoofddorp,
  39. Lorenskog,
  40. Oslo,
  41. Viken,
  42. Bydgoszcz,
  43. Bydgoszcz,
  44. Debica,
  45. Krakow,
  46. Krakow,
  47. Leczna,
  48. Lodz,
  49. Lubon,
  50. Siemianowice Slaskie,
  51. Torun,
  52. Trzebnica,
  53. Warszawa,
  54. Warszawa,
  55. Wroclaw,
  56. Wroclaw,
  57. Bratislava,
  58. Bratislava,
  59. Detva,
  60. Horne Srnie,
  61. Humenne,
  62. Humenné,
  63. Kosice,
  64. Liptovská Osada,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT04530838
  1. Isumi-city, Chiba
  2. Fukuoka-city, Fukuoka
  3. Fukuoka-shi, Fukuoka
  4. Osaka-City, Osaka
  5. Ritto-Shi, Shiga
  6. Nagoya-shi, Aichi
  7. Toyota-shi, Aichi
  8. Chiba-shi, Chiba
  9. Funabashi-city, Chiba
  10. Yotsukaido-shi, Chiba
  11. Yotsukaido-shi, Chiba
  12. Fukui-shi, Fukui
  13. Fukuoka-City, Fukuoka
  14. Fukuoka-city, Fukuoka
  15. Iizuka, Fukuoka
  16. Kasuga-city, Fukuoka
  17. Gifu-city, Gifu
  18. Ebetsu Shi, Hokkaido
  19. Sapporo shi, Hokkaido
  20. Sapporo, Hokkaido
  21. Akashi-City, Hyōgo
  22. Kawasaki-shi, Kanagawa
  23. Kumamoto Shi, Kumamoto
  24. Kumamoto-shi, Kumamoto
  25. Kuwana-city, MIE
  26. Nagano-shi, Nagano
  27. Kawachinagano, Osaka
  28. Ureshino-shi, Saga
  29. Hanyu-shi, Saitama
  30. Kumagaya-shi, Saitama
  31. Fuchu-city, Tokyo
  32. Nishitokyo-shi, Tokyo
  33. Setagaya-ku, Tokyo
  34. Setagaya-ku, Tokyo
  35. Shinjuku-ku, Tokyo
  36. Suginami-ku, Tokyo
  37. Kofu-city, Yamanashi
  38. Tsuru-shi, Yamanashi
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Pneumococcal DiseaseSafety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT04526574
  1. Miami Lakes, Florida
  2. Miami, Florida
  3. Wilmington, North Carolina
  4. Oklahoma City, Oklahoma
  5. Wauwatosa, Wisconsin
  6. Birmingham, Alabama
  7. Mobile, Alabama
  8. Chandler, Arizona
  9. Phoenix, Arizona
  10. Tempe, Arizona
  11. Redding, California
  12. San Diego, California
  13. San Diego, California
  14. Walnut Creek, California
  15. Coral Gables, Florida
  16. Crystal River, Florida
  17. Hialeah, Florida
  18. Jacksonville, Florida
  19. Miami, Florida
  20. Orlando, Florida
  21. Orlando, Florida
  22. Savannah, Georgia
  23. Stockbridge, Georgia
  24. Meridian, Idaho
  25. El Dorado, Kansas
  26. Wichita, Kansas
  27. Wichita, Kansas
  28. Metairie, Louisiana
  29. New Orleans, Louisiana
  30. Elkridge, Maryland
  31. Rockville, Maryland
  32. Saint Louis, Missouri
  33. Norfolk, Nebraska
  34. Omaha, Nebraska
  35. Las Vegas, Nevada
  36. Las Vegas, Nevada
  37. Binghamton, New York
  38. Endwell, New York
  39. Charlotte, North Carolina
  40. Greensboro, North Carolina
  41. Hickory, North Carolina
  42. Raleigh, North Carolina
  43. Raleigh, North Carolina
  44. Rocky Mount, North Carolina
  45. Rocky Mount, North Carolina
  46. Fargo, North Dakota
  47. Cincinnati, Ohio
  48. Cincinnati, Ohio
  49. Cleveland, Ohio
  50. Franklin, Ohio
  51. Warwick, Rhode Island
  52. Little River, South Carolina
  53. Mount Pleasant, South Carolina
  54. Bristol, Tennessee
  55. Nashville, Tennessee
  56. Austin, Texas
  57. Cedar Park, Texas
  58. Fort Worth, Texas
  59. Fort Worth, Texas
  60. Houston, Texas
  61. McKinney, Texas
  62. Pearland, Texas
  63. San Antonio, Texas
  64. Tomball, Texas
  65. Tomball, Texas
  66. Draper, Utah
  67. Salt Lake City, Utah
  68. Salt Lake City, Utah
  69. South Jordan, Utah
  70. Norfolk, Virginia
  71. Richmond, Virginia
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Pneumoniae Epidemiology Study in China
Official Title Epidemiological Study of Hospitalized Pediatric Pneumonia in China
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 of the lower respiratory tract infection. Clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. The chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. Bacterial isolates other than Streptococcus pneumoniae will be identified according to standardized procedures. S. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. Serotype will be determined using type-specific sera (Quellung reaction). Antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, Amoxycillin, Ofloxacin, Vancomycin, and imipenem be conducted using E-test according to standardized procedures at the central facilities.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
deep respiratory aspirate,pleural fluid,cerebrospinal fluid,serum
Sampling Method Non-Probability Sample
Study Population Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
Condition Pneumococcal Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
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
Estimated Enrollment
 (submitted: May 8, 2007)		1000
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
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 China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00471770
Other Study ID Numbers 0887X-101894
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2008