An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 19
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
研究概览
简要总结
The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
- •All subjects must not have received a prior influenza vaccination.
- •All subjects must not have had a prior influenza disease.
排除标准
- •Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
- •Acute illness at the start of the study.
- •Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
- •Known allergic reactions which might be caused by the ingredients of the vaccine.
- •Girls post-menarche: pregnancy or positive pregnancy-test
- •Multiple sclerosis or congenital or acquired immunodeficiencies.
研究组 & 干预措施
Influsplit SSW® 2005/2006 6-9 years Group
Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW® 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
干预措施: Influsplit SSW® 2005/2006 (Biological)
Influsplit SSW® 2005/2006 10-13 years Group
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0.
干预措施: Influsplit SSW® 2005/2006 (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
时间窗: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
时间窗: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
时间窗: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
次要结局
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group)
- Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years(21 days post-vaccination (Day 21))
- Number of Subjects With Solicited Local Symptoms(During the 4-day (Day 0-3) post-vaccination period following each dose and across doses)
- Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years(21 days post-vaccination (Day 21))
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years(21 days post-vaccination (Day 21))
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years(21 days post-vaccination (Day 21))
- Number of Subjects With Solicited General Symptoms(During the 4-day (Day 0-3) post-vaccination period following each dose and across doses)
- SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years(21 days post-vaccination (Day 21))
- Number of Subjects With Unsolicited Adverse Events.(During 31 days after the study vaccine dose (Day 0-30))