A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 12
- 主要终点
- Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
研究概览
简要总结
This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is an observer-blind study.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
- •Informed consent obtained from the participant prior to performance of any study-specific procedure.
- •A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
- •Healthy participants or medically stable patients as established by medical history and clinical examination.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any clinically significant laboratory abnormality.
- •History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
- •History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
- •Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- •Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
- •History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.
- •History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- •Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- •Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- •Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- •Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FLU/COVm_Dose Level 1
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose).
干预措施: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine (Biological)
FLU/COVm_Dose Level 2
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose).
干预措施: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine (Biological)
FLU/COVm_Dose Level 3
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose).
干预措施: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine (Biological)
Licensed Seasonal Influenza Vaccine Group
Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine.
干预措施: Licensed Seasonal Influenza Vaccine (Biological)
Licensed COVID-19 Vaccine Group
Participants receive a single intramuscular administration of a licensed COVID-19 vaccine.
干预措施: Licensed COVID-19 Vaccine (Biological)
结局指标
主要结局
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
时间窗: Day 1 to Day 3
The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening.
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
时间窗: Day 1 to Day 8
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
时间窗: Day 1 to Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
时间窗: Day 1 to Day 7
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Number of Participants with Solicited Systemic AEs
时间窗: Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
Number of Participants with Unsolicited AEs
时间窗: Day 1 to Day 28
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Day 1 to Day 181
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Day 1 to Day 181
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs).
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Day 1 to Day 181
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
次要结局
- GMI of Antigen 2 Titer(Day 1 to Day 29)
- GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)(At Day 29)
- Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)(Day 1 to Day 29)
- GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)(Day 1 to Day 29)
- Geometric Mean Increase (GMI) of Antigen 1 Titer(Day 1 to Day 29)
- GMT Of Antigen 2 Titer(At Day 29)
- Percentage of Participants with Antigen 2 SCR(Day 1 to Day 29)
- Geometric Mean Titer (GMT) Of Antigen 1 Titer(At Day 29)
- Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)(Day 1 to Day 29)
- Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)(At Day 1 and Day 29)