A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Occurrence of unsolicited adverse events
研究概览
简要总结
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential.
排除标准
- •Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
- •Administration of an influenza vaccine other than the study vaccines during the entire study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •History of hypersensitivity to vaccines.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
- •lactating women
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
研究组 & 干预措施
H5N1 Formulation 1 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine (Biological)
H5N1 Formulation 2 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine (Biological)
H5N1 Formulation 3 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine (Biological)
H5N1 Formulation 4 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine (Biological)
H5N1 Formulation 5 Group
Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) (Biological)
H5N1 Formulation 6 Group
Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) (Biological)
H5N1 Formulation 7 Group
Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) (Biological)
H5N1 Formulation 8 Group
Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
干预措施: Influenza Monovalent Whole virus (H5N1) (Biological)
结局指标
主要结局
Occurrence of unsolicited adverse events
时间窗: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
时间窗: During the entire study (Days 0 to 180)
To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
时间窗: At days 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
时间窗: At Days 0, 21, 42 and 180
Geometric mean titers (GMTs) of serum antibodies
Occurrence of solicited local and general adverse events
时间窗: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
次要结局
- To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers(At Days 0, 21, 42 and 180)
- To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes(At days 0, 21, 42 and 180)
- To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers(At Days 21, 42 and 180)