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

Completed

Conditions studied: Pneumococcal Disease

In brief

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.

Key facts

Study ID

NCT01128426

Run by

Pfizer

People needed

53902

Starts

2010-06-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-14

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.

Where it is running

• Northern California Kaiser Permanente — Oakland, California, United States

Full record on ClinicalTrials.gov

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