Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 20
- 主要终点
- Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
研究概览
简要总结
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
详细描述
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
- •Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- •Subjects aged 3 to 9 years:
- •Healthy children aged 3 to 9 years on the day of inclusion
- •Subjects aged 6 to 35 months:
- •Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
- •Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •Planned receipt of any vaccine prior to the Day 42 blood sample
- •Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- •Known or suspected 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- •Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- •Personal or family history of Guillain-Barré syndrome
- •Active neoplastic disease or a history of any hematologic malignancy
- •Known seizure/epilepsy history and/or taking anti-seizure medication
- •Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
- •Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
研究组 & 干预措施
A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
干预措施: Monovalent Subvirion A/H1N1 Influenza vaccine (Biological)
A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
干预措施: Monovalent Subvirion A/H1N1 Influenza vaccine (Biological)
Placebo Group
Participants will receive a placebo vaccine
干预措施: Normal saline solution (placebo) (Biological)
结局指标
主要结局
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
时间窗: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
时间窗: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
时间窗: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
时间窗: Days 0 to 7 post vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
时间窗: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
时间窗: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
时间窗: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
时间窗: Pre-vaccination (Day 0) and Day 21 post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
时间窗: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
次要结局
未报告次要终点