Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- Number of participants with unsolicited 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 formulations in all participants
- To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.
The secondary objectives 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 SN antibody responses in each group against each of the H3 antigens.
- To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.
- To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.
详细描述
Study duration per participant is approximately 1 year
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
- 18 Years 至 —（Adult, Older 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
Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with H3 strain 1 (Biological)
Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with H3 strain 1 and adjuvant (Biological)
Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with H3 strain 2 (Biological)
Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with H3 strain 2 and adjuvant (Biological)
Group 5: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with 2018-2019 NH H3 strain (Biological)
Group 6: Quadrivalent RIV Control, with adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old
干预措施: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant (Biological)
Group 7: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old
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 unsolicited adverse events
时间窗: From Day 0 to Day 28
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
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 adverse events of special interest
时间窗: From Day 0 to Day 365
Adverse events of special interest are collected throughout the study
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine
时间窗: From Day 0 to 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)
HAI Ab titer ≥ 40 [1/dil]
时间窗: From Day 0 to Day 365
Influenza vaccine antibody titers are measured by HAI assay
Number of participants with serious adverse events
时间窗: From Day 0 to Day 365
Serious adverse events are collected throughout the study
Clinical safety laboratory test results
时间窗: From Day 0 to Day 7
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine
时间窗: From Day 0 to Day 365
Influenza antibody titers are measured by HAI and SN assays
2-fold and 4-fold increase in SN titers
时间窗: From Day 0 to Day 28
Influenza vaccine antibody titers are measured by SN assay
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine
时间窗: From Day 0 to Day 90
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
次要结局
- HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens(Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365)
- 2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens(Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365)
- Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens(From Day 0 to Day 90)
- Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations(Day 0 and Day 28)