Effect 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

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-01-31

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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Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

Conditions

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Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Tympanocentesis

Intervention Type PROCEDURE

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

Nose/throat swab

Intervention Type PROCEDURE

To be performed at every study visit

Observational

Intervention Type BIOLOGICAL

Observational Study Only

Interventions

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Tympanocentesis

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

Intervention Type PROCEDURE

Nose/throat swab

To be performed at every study visit

Intervention Type PROCEDURE

Observational

Observational Study Only

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria

* Prior vaccination with any 7vPnC.
* Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.

Minimum Eligible Age

6 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No