A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL’s Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

bioCSL Pty Ltd0 个研究点目标入组 400 人开始时间: 2015年3月23日最近更新: 2015年3月30日

适应症

试验速览

暂无简介。

•* Males or females aged 5 to less than 9 years at the time of first study vaccination. * The subject’s parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements. * In good health, as determined by medical history and a targeted physical examination (if warranted).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 400
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•* Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines. * Clinical signs of significant active infection or an elevated oral temperature at study entry. * A clinically significant medical or psychiatric condition. * A history of seizures or febrile convulsions or Guillain-Barré syndrome. * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation. * Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry. * Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine. * Currently receiving treatment with warfarin or other anticoagulants.

发起方

bioCSL Pty Ltd