NCT01521897

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,143 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Months – 2 Years
• Healthy volunteers: Not accepted

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°)

Detailed 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.

Conditions

• Pneumococcal Vaccine
• Streptococcus Pneumoniae

Interventions

Type	Name	Description
BIOLOGICAL	7-valent vaccine injection	For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-01-01
• Completion: 2015-04-01
• First posted: 2012-01-31
• Last updated: 2016-01-20
• Results posted: 2016-01-20

Locations

1 site across 1 country: Japan