Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
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
- Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
研究概览
简要总结
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, 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 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
详细描述
To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).
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 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is aged ≥ 6 months to < 36 months.
- •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/guardian is willing and able to provide informed consent.
- •Parent/guardian is willing and able to meet protocol requirements.
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.
- •An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
- •Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- •Participation in any other 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.
- •Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
研究组 & 干预措施
Infants <12 Months
Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine
干预措施: Influenza Vaccine 2004-2005 Paediatric Formulation (Biological)
Toddlers ≥12 Months
Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine
干预措施: Influenza Vaccine 2004-2005 Paediatric Formulation (Biological)
结局指标
主要结局
Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
时间窗: Days 0-3 Post-dose
Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.
次要结局
未报告次要终点