Impact of Prevnar 13 on Ear Infections in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-21

Study Completion Date

2013-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Otitis Media Mastoiditis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Otitis media cases

No intervention

Intervention Type OTHER

Non interventional

Interventions

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No intervention

Non interventional

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No