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

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

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°)

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.

Inclusion Criteria:

• Infants at the age of more than 2 and less than 7 months
• Infants who have been vaccinated with Prevenar for the first time
• Infants expected to complete four vaccinations with Prevenar

Exclusion Criteria:

Vaccination with Prevenar must not be given to any of the following;

• History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
• Evident pyrexia
• Evident serious acute disease
• Any other infants or children ineligible for vaccination