A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Novartis4 个研究点分布在 1 个国家目标入组 125 人开始时间: 2006年7月1日最近更新: 2007年3月13日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 125
试验地点: 4
主要终点: antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adults aged >18 years

排除标准

•serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
•history of any anaphylaxis, serious vaccine reactions
•hypersensitivity against vaccine components
•history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
•known or suspected impairment/alteration of immune function
•more than one injection of influenza vaccine received or laboratory confirmed influenza disease
•within last 6 months: influenza vaccination received

结局指标

主要结局

antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

次要结局

safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

研究者

发起方

Novartis

申办方类型

Industry

研究点 (4)

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