At a glance
ClinicalIndex Comparison RecordN/ACompleted· 391 enrolled
Drug / intervention
No interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN
In Brief
An observational study evaluating No intervention for Acute Otitis Media and Mastoiditis. Completed, enrolled 391 participants across 8 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media, Mastoiditis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedJan 2011
Primary CompletionDec 2013
TodayJul 2026
First PostedJan 10, 2011
Enrollment StartMay 21, 2010
Primary CompletionDec 19, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.5 years ago
Interventions
No interventionother
Non interventional