NCT00479648已完成2 期
A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)
Seqirus1 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2007年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- seroprotection rate, HI titre & seroconversion/ significant increase
研究概览
简要总结
Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged ≥ 18 to ≤ 45 OR ≥ 60
- •Ability to provide pre-vaccination venous blood sample
排除标准
- •History of clinically significant medical conditions
- •Immunomodulative therapy
- •Acute infection
结局指标
主要结局
seroprotection rate, HI titre & seroconversion/ significant increase
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly PopulationInfluenzaNCT00318058GlaxoSmithKline84
Unknown
不适用
Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)InfluenzaNCT01424371Fraser Health1,000
已完成
4 期
Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) StatusInfluenzaNCT00442975Public Health England100
已完成
2 期
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly PopulationInfluenzaNCT00318149GlaxoSmithKline425
已完成
2 期
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in ElderlyInfluenzaNCT00386113GlaxoSmithKline74