At a glance
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Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
In Brief
An observational study evaluating 7-valent vaccine injection for Pneumococcal Vaccine and Streptococcus Pneumoniae. Completed, enrolled 1,143 participants across 1 site.
Detailed 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°)
Study Details
Timeline
Interventions
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.