A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 671
- 试验地点
- 27
- 主要终点
- Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
研究概览
简要总结
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
- •Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up
排除标准
- •Individuals recently vaccinated against influenza
- •Subjects with contraindications to receive influenza vaccine
研究组 & 干预措施
TIVc-High Dose
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
干预措施: Trivalent influenza vaccine (TIVc) (Biological)
TIVc-Full Dose
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
干预措施: Trivalent influenza vaccine (TIVc) (Biological)
TIVc- Half Dose
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
干预措施: Trivalent influenza vaccine (TIVc) (Biological)
TIVe
Subjects (6 to <48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to <36 months and IM/ 0.5 mL -for ages 36 to <48 months)
干预措施: Trivalent influenza vaccine-licensed (Biological)
结局指标
主要结局
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
时间窗: Day 50/Day 1
Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to \<48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
时间窗: Day 50 post vaccination
Immunogenicity was assessed in terms number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
时间窗: Day 1 to Day 3
Differences in percentages of subjects (6 to \<48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.
次要结局
- Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 50 post vaccination)
- Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 1, Day 50 post vaccination)
- Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 1 and Day 50 post vaccination)
- Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 1 and Day 50 post vaccination)
- Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 1 and Day 50 post vaccination)
- Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine(Day 1 to Day 7)
- Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine(Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209)
- Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine(Day 50 post vaccination over day 1)