NCT00562484已完成4 期
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
Seqirus27 个研究点 分布在 2 个国家目标入组 7,500 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7,500
- 试验地点
- 27
- 主要终点
- CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
研究概览
简要总结
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
- •Non pregnant/ non lactating females
排除标准
- •Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
- •Vaccination against influenza in the previous 6 months
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- •Known history of Guillain-Barré Syndrome;
- •Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
- •History of neurological disorders or seizures
- •Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
- •Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
- •Administration of immunoglobulins and/or any blood products;
- •Participation in a clinical trial or use of an investigational compound;
- •Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
- •Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
结局指标
主要结局
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
时间窗: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
次要结局
- CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains(2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
- Incidence of Influenza-like Illness (ILI)(2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
- Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008(21 days after study vaccination)
- Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009(21 days after study vaccination)
- Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008(21 days after study vaccination)
- Frequency and Intensity of Local and Systemic Solicited Symptoms(5 days after study vaccination)
- Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008(21 days after study vaccination)
- Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009(21 days after study vaccination)
- Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009(21 days after study vaccination)
- Frequency and Intensity of Unsolicited Adverse Events (UAEs)(21 days after study vaccination)
- Serious Adverse Events (SAEs)(180 days after study vaccination)
- New Onsets of Chronic Illness (NOCI)(180 days after study vaccination)
研究者
研究点 (27)
Loading locations...
相似试验
已完成
4 期
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), InactivatedSeasonal InfluenzaNCT05512494Sinovac Biotech Co., Ltd1,260
已完成
3 期
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in AdultsVirus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsInfluenzaNCT03301051Medicago10,160
已完成
4 期
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 SeasonInfluenzaHealthyNCT03158038MedImmune LLC300
已完成
4 期
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 SeasonHealthyInfluenzaNCT02743117MedImmune LLC301
已完成
3 期
Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, QuadrivalentSeasonal InfluenzaNCT05431725Sinovac Biotech Co., Ltd2,202