Impact of Prevnar 13 on Ear Infections in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01272999
First received: December 8, 2010
Last updated: September 10, 2014
Last verified: September 2014

December 8, 2010
September 10, 2014
December 2010
December 2013   (final data collection date for primary outcome measure)
  • S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ] [ Designated as safety issue: No ]
  • S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ] [ Designated as safety issue: No ]
  • S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ] [ Designated as safety issue: No ]
  • The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ] [ Designated as safety issue: No ]
  • The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ] [ Designated as safety issue: No ]
  • The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01272999 on ClinicalTrials.gov Archive Site
  • The antimicrobial susceptibility patterns for each isolate [ Time Frame: Study Completion (36 months from study start) ] [ Designated as safety issue: No ]
  • The primary clinical diagnosis of each child from whom S pneumoniae is isolated [ Time Frame: Study Completion (36 months from study start) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Prevnar 13 on Ear Infections in Children
Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children

Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.

Non-Probability Sample

Children aged 6 weeks to 18 years

  • Acute Otitis Media
  • Mastoiditis
Not Provided
1
Otitis media cases
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
391
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database.
  • S pneumoniae identified from middle ear fluid or mastoiditis sample.
  • Specimen obtained from children aged up to 18 years.

Exclusion Criteria:

  • As this is an observational, laboratory based database study, there are no exclusion criteria
Both
6 Weeks to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272999
6096A1-4024, B1851040
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP