CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 239 enrolled
Drug / intervention
Observational +2 morebiological
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.

Search/NCT01199016
NCT01199016N/ACompleted
CompareCT.gov

"a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children

Pfizer·observational·Posted Sep 10, 2010·Updated Mar 1, 2017

In Brief

An observational study evaluating Tympanocentesis, Nose/throat swab, and 1 other intervention for Otitis Media. Completed, enrolled 239 participants across 7 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--
ConditionsOtitis Media
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.8 years ago

Interventions

Tympanocentesisprocedure

To be performed as needed on children presenting with acute otitis media

Nose/throat swabprocedure

To be performed at every study visit

Observationalbiological

Observational Study Only