Clinical Trial: Impact of Prevnar 13 on Ear Infections in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children
Brief Summary: 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.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome:
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ]
Original Primary Outcome:
- The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ]
- The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ]
- The primary endpoint is the S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ]
Current Secondary Outcome:
- The antimicrobial susceptibility patterns for each isolate [ Time Frame: Study Completion (36 months from study start) ]
- The primary clinical diagnosis of each child from whom S pneumoniae is isolated [ Time Frame: Study Completion (36 months from study start) ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: December 8, 2010
Date Started: December 2010
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014
