A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
2017年7月21日 更新者：MedImmune LLC
A Phase 2, Open-Label, Single Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to Less Than 60 Months of Age
Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.
研究概览
详细说明
This was a Phase 2, open-label, single-arm, multicenter study designed to evaluate vaccine virus shedding and safety of trivalent influenza virus vaccine live, intranasal in children 6 to < 60 months of age.
Enrollment of approximately 200 participants was stratified by age, with 100 participants 6 to < 24 months of age (who reached their sixth month but not their second year birthday) and 100 participants 24 to < 60 months of age (who reached their second year but not their fifth year birthday).
Baseline medical history data collection included the participants prior receipt of influenza vaccine or history of laboratory-confirmed influenza illness in the previous influenza season.
研究类型
介入性
注册 (实际的)
200
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72205
- Little Rock Allergy & Asthma Clinic, PA
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Georgia
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Marietta、Georgia、美国、30062
- Pediatric and Adolescent Medicine, PA (PAMPA)
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Kentucky
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Bardstown、Kentucky、美国、40004
- Kentucky Pediatrics/Adult Research
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Louisiana
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Metairie、Louisiana、美国、70006
- Benchmark Research
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New York
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Cortland、New York、美国、13045
- Health Sciences Research Center
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Elmira、New York、美国、14901
- Health Sciences Research Center
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Endwell、New York、美国、13760
- Regional Clinical Research Inc.
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Oklahoma
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Oklahoma City、Oklahoma、美国、73132
- Grand Prairie Pediatrics & Allergy Clinic
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15241
- Primary Physicians Research , Inc
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Texas
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Houston、Texas、美国、77004
- Med-Pro Research Inc.
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New Braunfels、Texas、美国、78130
- Central Texas Health Research
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San Angelo、Texas、美国、76904
- Benchmark Research
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Utah
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Layton、Utah、美国、84041
- Wee Care Pediatrics
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Provo、Utah、美国、84604
- Utah Valley Pediatrics
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Virginia
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Burke、Virginia、美国、22015
- PI-Coor Clinical Research, LLC
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Vienna、Virginia、美国、22180
- Advanced Pediatrics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 4年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female, 6 months to less than 60 months of age (reached their 6th month but not yet reached their 5th year birthday) at the time of study vaccination
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the participants parent/legal representative
- Ability of the participants parent/legal representative to understand and comply with the requirements of the study
- Participants parent/legal representative available by telephone
- Ability to complete follow-up period of 180 days after study vaccination as required by the protocol
Exclusion Criteria:
- History of hypersensitivity to any component of trivalent influenza virus vaccine live, intranasal, including egg or egg products, monosodium glutamate, or porcine gelatin
- History of hypersensitivity to gentamicin
- History of Guillain-Barré syndrome
- Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to study vaccination (i.e., children with recent persistent asthma were excluded); or history of severe persistent asthma according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report
- Acute febrile (greater than or equal to [>=] 100.0 degree Fahrenheit [°F] oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to study vaccination
- Any known immunosuppressive condition or immune deficiency disease (including human immunodeficiency virus [HIV] infection), or ongoing receipt of any immunosuppressive therapy
- Household contact who was immunocompromised (participants were also to avoid close contact with immunocompromised individuals for at least 21 days after study vaccination)
- Use of aspirin or aspirin-containing products within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination
- Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Use of any intranasal medication within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Administration of any live virus vaccine within the 30 days prior to study vaccination, or expected receipt through 30 days after study vaccination
- Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to study vaccination, or expected receipt through 14 days after study vaccination
- Receipt of any investigational agent within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert was permitted)
- Receipt of any blood product within the 90 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Family member or household contact who was an employee of the research center or otherwise involved with the conduct of the study
- Any condition that in the opinion of the investigator would have interfered with evaluation of the vaccine or interpretation of study results
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Cohort 1: Participants Between 6 to < 24 Months Age
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study.
Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
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A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study.
Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
其他名称：
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实验性的：Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study.
Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
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A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study.
Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants Who Shed Any Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays.
Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28.
Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed A/H1N1 Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays.
Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28.
Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed A/H3N2 Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays.
Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28.
Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed B Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays.
Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28.
Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Duration of Any Vaccine Virus Shedding
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed any vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed A/H1N1 Vaccine Virus Shedding
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed A/H3N2 Vaccine Virus Shedding
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed B Vaccine Virus Shedding
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed B strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed B Shed Vaccine Virus on Any Day
大体时间：Days 1-28 after study vaccination (up to Day 28)
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Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes.
Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C.
Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C.
After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes.
Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C.
Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C.
After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
大体时间：Days 1-28 after study vaccination (up to Day 28)
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The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes.
Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C.
Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C.
After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
大体时间：Days 0-28 after vaccination (up to Day 28)
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REs were predefined solicited events that could potentially occur after vaccination.
The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Days 0-28 after vaccination (up to Day 28)
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Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
大体时间：Days 0-180 after vaccination (up to 6.5 months)
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An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.
SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).
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Days 0-180 after vaccination (up to 6.5 months)
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Number of Participants With REs in Relation to Any Vaccine Virus Shedding
大体时间：Days 0-28 after study vaccination (up to Day 28)
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REs were predefined solicited events that could potentially occur after vaccination.
The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.
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Days 0-28 after study vaccination (up to Day 28)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Raburn Mallory, M.D.、MedImmune LLC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2006年5月1日
初级完成 (实际的)
2006年7月1日
研究完成 (实际的)
2006年12月1日
研究注册日期
首次提交
2006年6月22日
首先提交符合 QC 标准的
2006年6月22日
首次发布 (估计)
2006年6月26日
研究记录更新
最后更新发布 (实际的)
2017年7月24日
上次提交的符合 QC 标准的更新
2017年7月21日
最后验证
2017年7月1日
更多信息
与本研究相关的术语
药物和器械信息、研究文件
研究美国 FDA 监管的药品
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研究美国 FDA 监管的设备产品
不
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