Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

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

53902 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.

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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.