Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
2016年4月12日 更新者:Sanofi Pasteur, a Sanofi Company
Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.
Observational Objectives:
- To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
- To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
- To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
研究概览
详细说明
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
研究类型
介入性
注册 (实际的)
242
阶段
- 第三阶段
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
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Georgia
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Marietta、Georgia、美国、30062
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North Carolina
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Durham、North Carolina、美国、27704
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Ohio
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Dayton、Ohio、美国、45404
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15241
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Washington
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Seattle、Washington、美国、98040
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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 11个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
- Available for the duration of the study.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
- Parent/legal acceptable representative willing and able to provide informed consent.
- Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
- Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
- Previous history of influenza vaccination (Group 2 subjects only).
- Receipt of any vaccine in the 14 days prior to enrollment.
- An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
- Known bleeding disorder.
- Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this 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 that could interfere with trial conduct or completion.
- Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
- Known HIV, hepatitis B, or hepatitis C infection.
- Receipt of blood or blood-derived products within the past 2 months.
- 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.
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:预防
- 分配:非随机化
- 介入模型:并行分配
- 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:Fluzone® Vaccine-Primed Group
Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
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0.25 mL, Intramuscular
其他名称:
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有源比较器:Influenza Vaccine-Naive Group
Participants who have never received influenza vaccine (and not in Study GRC27)
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0.25 mL, Intramuscular
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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Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
大体时间:Day 28 Post-vaccination
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Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
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Day 28 Post-vaccination
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.
大体时间:Day 28 Post-vaccination
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Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
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Day 28 Post-vaccination
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Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.
大体时间:Day 28 Post-vaccination
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Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA). Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method. The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay. |
Day 28 Post-vaccination
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Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
大体时间:Day 28 post-vaccination
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Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).
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Day 28 post-vaccination
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Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
大体时间:Day 28 post-vaccination
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Antibodies to polio viruses were measured by a serum neutralization assay.
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Day 28 post-vaccination
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Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.
大体时间:Days 0 up to 7 post-vaccination
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Solicited injection site reactions: Tenderness, erythema and swelling.
Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
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Days 0 up to 7 post-vaccination
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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。
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。
有用的网址
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
2005年10月1日
初级完成 (实际的)
2006年1月1日
研究完成 (实际的)
2007年9月1日
研究注册日期
首次提交
2009年4月20日
首先提交符合 QC 标准的
2009年4月20日
首次发布 (估计)
2009年4月21日
研究记录更新
最后更新发布 (估计)
2016年4月14日
上次提交的符合 QC 标准的更新
2016年4月12日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Erasme University HospitalRoche Diagnostics; LHUB-ULB终止
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