Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 654
- 试验地点
- 29
- 主要终点
- Antibody Responses After the First and Second Vaccinations
研究概览
简要总结
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 6 to 35 months 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
排除标准
- •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
结局指标
主要结局
Antibody Responses After the First and Second Vaccinations
时间窗: 21 days after each vaccination
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
时间窗: Day 1 to 7
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
时间窗: Day 22 to 28
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
次要结局
- Geometric Mean Titers (GMTs) Based on Baseline Seropositivity(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Antibody Persistence by Geometric Mean Titers (GMT)(6 months (Day 202) and 12 months (Day 387) after second vaccination)
- Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Antibody Response Based on Baseline Seropositivity(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Immunogenicity Measurement by Geometric Mean Titers (GMT)(21 days after each vaccination)