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プレベナーの日本における特別使用効果調査(規制当局による市販後調査計画)

基本情報

NCT ID
NCT01521897
ステータス
完了
試験のフェーズ
-
試験タイプ
観察
目標被験者数
1,143
治験依頼者名
Pfizer

概要

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°)

対象疾患

Pneumococcal VaccineStreptococcus Pneumoniae

介入

7-valent vaccine injection(BIOLOGICAL)

依頼者(Sponsor)

実施施設 (1)

医療法人 横山小児科医院

Kasuga, Fukuoka, Japan