A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

Novartis Vaccines6 个研究点分布在 1 个国家目标入组 125 人2011年5月

适应症Influenza

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Influenza
发起方: Novartis Vaccines
入组人数: 125
试验地点: 6
主要终点: To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
状态: 已完成
最后更新: 14年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

注册库

clinicaltrials.gov

开始日期

2011年5月

结束日期

2011年6月

最后更新

14年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Novartis Vaccines

责任方

Sponsor

入排标准

入选标准

•Healthy, adult and elderly volunteers over 18 years

排除标准

•Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

结局指标

主要结局

To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly

时间窗: 22 days including follow-up period

To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.