Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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San Jose、哥斯达黎加
- Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
For additional entry criteria, please refer to protocol.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：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：2x7.5adj
Two doses of MF59 adjuvanted (adj) A/H1N1
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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实验性的：7.5adj_1_8
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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实验性的：7.5adj_1_22
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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实验性的：15_1_22
A/H1N1 on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
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实验性的：2x15_1_22
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
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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 Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
大体时间：Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
大体时间：Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). |
Day 1 to day 387
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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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Age Distribution at Baseline
大体时间：Baseline
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Baseline
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
大体时间：Day 1 to day 387
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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HI GMRs, in 3 to <9 Years and 9 to 17 Years
大体时间：Day 1 to day 387
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Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). |
Day 1 to day 387
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HI GMR, in Adults 18 to 64 Years
大体时间：Day 1 to day 387
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Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
大体时间：7 days and 21 days after each vaccination
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Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). |
7 days and 21 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
大体时间：7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination |
7 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
大体时间：7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. |
7 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
大体时间：7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. |
7 days after each vaccination
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合作者和调查者
调查人员
- 研究主任：Novartis Vaccines、Novartis Vaccines
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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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