日本の就学前児童を対象とした、IMOVAX POLIO®皮下注射ワクチンの追加接種に関する研究

基本情報

NCT ID

NCT02005536

ステータス

完了

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

60

治験依頼者名

Sanofi

概要

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: * To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: * To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). * To investigate the safety after dosing of SP059 as 2nd booster.

対象疾患

介入

依頼者（Sponsor）