NCT00491985已完成2 期
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.
研究概览
简要总结
This is an open, randomized, multicenter clinical trial.
Objectives:
- To describe the safety profiles during the 21 days following each primary and booster injection.
- To describe the immune response 21 days after each primary and booster injection of each formulation.
- To describe the antibody persistence after the first 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
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •Children/Adolescents aged ≥ 2 years to < 18 years:
- •Aged ≥ 2 years to < 18 years on the day of inclusion.
- •Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate.
- •For a female, inability to bear a child or negative urine pregnancy test (as applicable).
- •For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable).
- •Infants/toddlers aged ≥ 6 months to < 2 years:
- •Aged ≥ 6 months to < 2 years on the day of inclusion.
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2 kg.
- •Informed Consent Form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
- •Subject who completed vaccination according to the national immunization schedule.
排除标准
- •All subjects:
- •Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- •Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- •Chronic illness at a stage that could interfere with trial conduct or completion.
- •Blood or blood-derived products received in the past 3 months.
- •Any vaccination in the 4 weeks preceding the first trial vaccination.
- •Vaccination planned in the 4 weeks following any trial vaccination.
- •History of the H5N1 infection (confirmed either clinically, serologically or virologically).
- •Known HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
- •Previous vaccination with an avian flu vaccine.
- •Subject at high risk of the H5N1 infection during the trial.
- •Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- •Febrile illness (rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
- •Children/Adolescents aged ≥ 2 years to < 18 years:
- •Breast-feeding mothers.
- •Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age).
- •Infants/toddlers aged ≥ 6 months to < 2 years:
- •History of seizures.
研究组 & 干预措施
Study Group 1
Experimental
Subjects aged 9 to 17 years
干预措施: A/H5N1 Inactivated, split-virion pandemic influenza vaccine (Biological)
Study Group 2
Experimental
Subjects aged 3 to 8 years
干预措施: A/H5N1 Inactivated, split virion pandemic influenza vaccine (Biological)
Study Group 3
Experimental
Subjects aged 6 to 35 months
干预措施: A/H5N1 Inactivated, split virion pandemic influenza vaccine (Biological)
结局指标
主要结局
To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.
时间窗: 21 Days post-vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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