Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
研究概览
简要总结
Primary Objective:
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.
Observational Objective:
To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
详细描述
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
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
- 2 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
- •Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
- •Considered to be in good health on the basis of reported medical history and history-directed physical examination.
- •Available for the duration of the study.
- •Parent/guardian willing and able to provide informed consent.
- •Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- •Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
排除标准
- •Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- •Previous history of influenza vaccination or documented history of influenza infection.
- •Receipt of any vaccine in the 7 days prior to enrollment.
- •An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- •Known bleeding disorder.
- •Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
- •Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- •Personal or immediate family history of congenital immune deficiency.
- •Developmental delay, neurologic disorder, or seizure disorder.
- •Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
- •Known HIV-positive or HBsAg-positive mother.
- •Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
- •Blood or blood-derived products received in the past 2 months.
- •Prior history of Guillain-Barré syndrome.
- •Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
研究组 & 干预措施
Group 1
Participants aged 6 to 12 Weeks at enrollment
干预措施: Influenza virus vaccine (2004-2005 Formulation) (Biological)
Group 2
Participants aged 24 to 36 Weeks at enrollment
干预措施: Influenza virus vaccine (2004-2005 Formulation) (Biological)
结局指标
主要结局
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
时间窗: Day 0 to Day 7 post-vaccination
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
次要结局
未报告次要终点