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Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Streptococcus Pneumoniae Clinical Trial

Official title:
Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)

Clinical Trial Summary

This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.

This surveillance will specifically focus on the occurrence of the following:

1. Local reactions at the injection site

2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Clinical Trial Description

This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01521897
Study type Observational
Source Pfizer
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date April 2015
View Details
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