A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
研究概览
简要总结
This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.
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
- Single (Participant)
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
- •Male and female previously unvaccinated healthy children aged 6 to <36 months.
排除标准
- •Any known or suspected impairment of the immune system, any serious disease.
- •Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- •Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.
结局指标
主要结局
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
时间窗: Day 1 to Day 50 post vaccination
The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.
Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.
时间窗: Day 1, Day 50
The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.
次要结局
- Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer(Day 50)
- Geometric Mean Ratios (GMR)(Day 50/Day 1)
- Percentage of Subjects With HI Titers >1:40(Day 50)