NCT02212106已完成4 期
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
Seqirus22 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 22
- 主要终点
- The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
研究概览
简要总结
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged 5 to less than 9 years at the time of first study vaccination.
- •The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- •In good health, as determined by medical history and a targeted physical examination (if warranted).
排除标准
- •Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- •Clinical signs of significant active infection or an elevated oral temperature at study entry.
- •A clinically significant medical or psychiatric condition.
- •A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- •Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- •Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- •Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- •Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- •Currently receiving treatment with warfarin or other anticoagulants.
结局指标
主要结局
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
时间窗: 7 days after each administration of vaccine.
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
次要结局
- The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
- The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
- The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
- The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
- The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
- The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.(7 days after each administration of vaccine.)
研究者
研究点 (22)
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