Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
研究概览
简要总结
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.
Observational Objectives:
To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.
To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.
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 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
- •Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
- •Participant is available for the duration of the study.
- •Parent/legal acceptable representative is willing and able to provide informed consent.
- •Parent/legal acceptable representative is willing and able to meet protocol requirements.
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
排除标准
- •Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- •Documented history of influenza infection.
- •An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
- •Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- •Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the 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.
- •Known Human immunodeficiency virus (HIV)-positive mother.
- •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.
结局指标
主要结局
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
时间窗: Day 14 post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
次要结局
未报告次要终点