A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female aged 18-59 years at the time of the first vaccination.
- •Free of obvious health problems
排除标准
- •Use of non-registered products
- •Administration of immune-modifying drugs.
- •Administration of vaccine 30 days before enrolment in study.
- •Immunosuppressive or immunodeficient condition.
- •Hypersensitivity to a previous dose of influenza vaccine
- •Previous vaccination against influenza in 2006
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- •History of confirmed influenza infection within the last 12 Months.
- •Acute disease at the time of enrolment/vaccination.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine
结局指标
主要结局
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
时间窗: At Day 0 and at Day 21.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
时间窗: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
时间窗: At Day 0 and at Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
时间窗: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer.
次要结局
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(From study start to study end, from Day 0 to Day 30)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 30-day follow-up period (Days 0-29) after vaccination)