临床试验/NCT01758185

NCT01758185已完成4 期

Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Beijing Center for Disease Control and Prevention2 个研究点分布在 1 个国家目标入组 3,308 人开始时间: 2011年8月1日最近更新: 2013年3月28日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 3,308
试验地点: 2
主要终点: Incidence rate of adverse events of the inactivated split influenza vaccine

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

The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

详细描述

A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 3 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•more than three years in good healthy

排除标准

•current infectious fever or acute disease
•upper respiratory infectious symptom within 6m
•a history of allergy
•laboratory confirmed influenza
•autoimmune disease
•have get influenza vaccine since 2008

结局指标

主要结局

Incidence rate of adverse events of the inactivated split influenza vaccine

时间窗: two years

次要结局

Antibody titre of the inactivated split influenza vaccine(two years)

研究者

发起方

Beijing Center for Disease Control and Prevention

申办方类型

Other Gov

责任方

Sponsor

研究点 (2)

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EUCTR2015-003544-39-LTFIDEC - Fighting Infectious Diseases in Emerging Countries