NCT00389857已完成4 期
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
研究概览
简要总结
To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and 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 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 (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 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 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.
结局指标
主要结局
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
时间窗: 14 days post-vaccination
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 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
研究者
研究点 (1)
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