A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 40
- 主要终点
- Presence of unsolicited AEs reported up to 28 days after injection
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include:
Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control.
Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181
详细描述
Approximately 6 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)
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
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Presence of unsolicited AEs reported up to 28 days after injection
时间窗: Up to 28 days after injection
Number of participants with unsolicited AEs
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
时间窗: Within 30 minutes after injection
Number of participants with unsolicited systemic immediate adverse events (AEs)
Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
时间窗: Up to 7 days after injection
Number of participants with solicited systemic reactions
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
时间窗: From baseline up to 6 months
Number of participants with serious adverse events (SAEs)
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
时间窗: Up to 28 days after injection
Number of participants with medically attended adverse events (MAAE)s
Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
时间窗: Up to 28 days after injection
Number of participants with out-of-range biological test results
Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
时间窗: Up to 7 days after injection
Number of participants with solicited injection site reactions
次要结局
- Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29(From baseline up to 6 months)
- Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181(At Day 29, Day 91, and Day 181)
- 2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181(From Day 01 through Day 91 and Day 01 through Day 181)
- 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181(From Day 01 through Day 29 and Day 01 through Day 181)
- Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181(At Day 29, Day 91, and Day 181)
- Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29(From baseline up to 6 months)
- HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181(At Day 29, Day 91 and Day 181)
- HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181(At Day 01, Day 29, D91 and D181)
- Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181(At Day 01, Day 29, Day 91, and Day 181)