A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,411
- 试验地点
- 87
- 主要终点
- Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)
研究概览
简要总结
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
- •For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
- •At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
- •At least 18 and <65 years of age, at the time of signing the ICF.
- •At least 65 years of age or older, at the time of signing the ICF.
排除标准
- •Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day
- •Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day
- •Participants meeting this criterion may be rescheduled within the 28-day screening window.
- •Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- •Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
- •Participant has tested positive for influenza by local health authority-approved testing methods within 150 days (for Part A) or 180 days (for Parts B and C) prior to Day
- •Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
- •Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
- •Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
- •Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day
- •Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day
- •Participant is not aware whether they have received an influenza vaccine in the most recent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).
- •Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-1010
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
干预措施: mRNA-1010 (Biological)
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.
干预措施: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)
时间窗: Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ.
Percentage of Participants Reaching Seroconversion, as Measured by HAI
时间窗: Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Seroconversion rate was defined as the percentage of participants with either a Baseline HAI titer \<1:10 and a postbaseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in postbaseline HAI antibody titer. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were converted to the ULOQ.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to 7 days after study injection
Solicited ARs, representative of vaccine reactogenicity, were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Per prespecified analysis, only solicited ARs that were assessed and confirmed by the Investigator as both serious and related to IP were recorded as an adverse event. These adverse events were recorded as a serious AE (SAE) and are included in the summary of SAEs in the "Reported Adverse Events" section.
Number of Participants With Unsolicited Adverse Events (AEs)
时间窗: Up to 28 days after study injection
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs included any AE not collected as a solicited AR, and also included solicited ARs assessed and confirmed as both serious and related by the Investigator. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation
时间窗: Day 1 through Day 181
An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
次要结局
- Percentage of Participants With HAI Titer ≥1:40(Day 29)
- Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay(Baseline (Day 1) to Day 29)