Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 682
- 试验地点
- 35
- 主要终点
- Number of participants with unsolicited AEs
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 up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) [adults ≥ 65 years of age only], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.
详细描述
Study duration is approximately 12 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a parallel-group prevention study with up to 6 arms that will be blinded to participants, investigators / sub-investigators, outcomes assessors, and laboratory personnel (with the exception of the sentinel safety portion of the study, which will be open-label). The Sponsor study staff will be unblinded (except laboratory testing personnel).
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
- •Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •Previous history of myocarditis, pericarditis, and / or myopericarditis
- •Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
- •Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- •NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose
participants will receive a single dose of QIV mRNA vaccine (low dose)
干预措施: Quadrivalent Influenza mRNA Vaccine MRT5413 (Biological)
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose
participants will receive a single dose of QIV mRNA vaccine (medium dose)
干预措施: Quadrivalent Influenza mRNA Vaccine MRT5413 (Biological)
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose
participants will receive a single dose of QIV mRNA vaccine (high dose)
干预措施: Quadrivalent Influenza mRNA Vaccine MRT5413 (Biological)
Group 4: RIV4
participants will receive a single dose of RIV4 vaccine
干预措施: Quadrivalent Recombinant Influenza Vaccine (Biological)
Group 5: QIV-SD
participants will receive a single dose of QIV-SD vaccine
干预措施: Quadrivalent Influenza Standard Dose Vaccine (Biological)
Group 6: QIV-HD
participants will receive a single dose of QIV -HD vaccine (for elderly only)
干预措施: Quadrivalent Influenza High-Dose Vaccine (Biological)
结局指标
主要结局
Number of participants with unsolicited AEs
时间窗: Up to 28 days after injection
AEs that do not fulfill the conditions of solicited reactions
Number of participants with medically attended adverse events (MAAE)s
时间窗: Up to 180 days after injection
AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
时间窗: At Day 29
Percentage of participants with 2-fold and 4-fold rise in HAI titers
时间窗: At Day 1 and Day 29
Individual Hemagglutination inhibition (HAI) titer
时间窗: At Day 1 and Day 29
Antibody titers are expressed as GMTs at baseline and post-baseline
Individual HAI titer ratio
时间窗: At Day 1 and Day 29
Ratios of antibody titers measured by HAI in each group before and after vaccination
Number of participants archiving HAI seroconversion against Antigens
时间窗: At Day 1 and Day 29
Number of participants with titer \< 10 \[1/dil\] at Day 1 and post-vaccination titer ≥ 40 \[1/dil\] at Day 29, or titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold-rise in titer \[1/dil\] at Day 29
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
时间窗: At Day 1 and Day 29
Number of participants with immediate adverse events (AEs)
时间窗: Within 30 minutes after injection
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
时间窗: Up to 7 days after injection
Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants with serious adverse events (SAEs)
时间窗: From Day one to Day 366
SAEs reported throughout the study
Number of participants with out-of-range biological test results
时间窗: Up to 8 days after injection
Out-of-range biological test results (including shift from baseline values)
次要结局
- Neutralizing Ab titers(At Day 1 and Day 29)
- Percentage of participants with 2-fold and 4-fold increase in neutralizing titers(At Day 1 and Day 29)
- Individual HAI Ab titer ratio(Day 1, Day 91, Day 181 and Day 366)
- Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil](At Day 91, Day 181 and Day 366)
- Individual antibodies HAI titer ratio(Day 1, Day 91, Day 181 and Day 366)
- Individual neutralizing antibodies titer ratio(At Day 1 and Day 29)