Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Number of participants with immediate adverse events
研究概览
简要总结
The primary objectives of the study are:
- To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations.
- To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.
The secondary objectives of the study are:
- To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
- To describe HAI and SN antibody responses in each group against each of the H3 antigens.
- To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
详细描述
Study duration per participant is approximately 90 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Quadrivalent RIV with H3 strain 1
1 injection of Quadrivalent RIV containing H3 strain 1
干预措施: Quadrivalent RIV with H3 strain 1 (Biological)
Quadrivalent RIV with H3 strain 2
1 injection of Quadrivalent RIV containing H3 strain 2
干预措施: Quadrivalent RIV with H3 strain 2 (Biological)
Quadrivalent RIV with H3 strain 3
1 injection of Quadrivalent RIV containing H3 strain 3
干预措施: Quadrivalent RIV with H3 strain 3 (Biological)
Quadrivalent RIV with H3 strain 4
1 injection of Quadrivalent RIV containing H3 strain 4
干预措施: Quadrivalent RIV with H3 strain 4 (Biological)
Quadrivalent RIV Control
1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain
干预措施: Quadrivalent RIV with 2018-2019 NH H3 strain (Biological)
结局指标
主要结局
Number of participants with immediate adverse events
时间窗: Within 30 minutes after vaccination
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
时间窗: From Day 0 to Day 7
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Number of participants with unsolicited adverse events
时间窗: From Day 0 to Day 28
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
HAI antibody titers against HA influenza antigens in quadrivalent RIV control group
时间窗: From Day 0 to Day 90
Influenza vaccine antigens are measured by HAI assay
Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group
时间窗: Day 28
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28
Number of participants with serious adverse events
时间窗: From Day 0 to Day 90
Serious adverse events are collected throughout the study
Number of participants with adverse events of special interest
时间窗: From Day 0 to Day 90
Adverse events of special interest are collected throughout the study
Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group
时间窗: From Day 0 to Day 90
Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group
时间窗: From Day 0 to Day 90
Influenza vaccine antigens are measured by HAI assay
次要结局
- Number of participants with seroconversion to influenza H3 antigens(Day 28)
- HAI and SN antibody titers against influenza H3 antigens(From Day 0 to Day 90)
- 2-fold and 4-fold increase in SN antibody titers against HA influenza antigens in quadrivalent RIV control group(From Day 0 to Day 90)
- Individual ratio of HAI and SN titers against influenza H3 antigens(From Day 0 to Day 90)
- Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens(From Day 0 to Day 90)
- 2-fold and 4-fold increase in SN antibody titers against influenza H3 antigens(From Day 0 to Day 90)