Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
研究概览
简要总结
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
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 (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 (5.5 lbs).
排除标准
- •Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- •An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) 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 or planned 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 personal 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.
- •Received any vaccinations within the preceding 14 days (enrollment may be deferred).
研究组 & 干预措施
Influenza vaccine Naive/Inadequately Primed
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
干预措施: 2007-2008 Influenza Virus Vaccine (Biological)
Influenza Vaccine Primed
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
干预措施: 2007-2008 Influenza Virus Vaccine (Biological)
结局指标
主要结局
Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
时间窗: Days 0-3 post-dose
Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
次要结局
未报告次要终点