A phase 3 randomized, observer-blind, controlled study to evaluate the immunogenicity, reactogenicity and safety of an mRNA-based seasonal influenza vaccine, in adults 18-64 years of age
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 8
- 主要终点
- •HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29
研究概览
简要总结
To demonstrate the non-inferiority of the investigational study intervention in adults 18-64 YOA as compared to adults aged 65 YOA and older in study FLU SV MRNA-006 in terms of humoral immune response to the HA and NA antigens. To demonstrate the non-inferiority of the investigational study intervention as compared to Flu D-TIV in adults 18-64 YOA in terms of humoral immune response to the HA antigens. To evaluate the safety and reactogenicity of the study interventions.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
- •Written or witnessed (physically or digitally) informed consent obtained from the participant/LAR(s) of the participant prior to performance of any study-specific procedure
- •Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
- •A male or female participant between and including 18 to 64 YOA at the time of the study intervention administration.
- •For further inclusion criteria, kindly refer to the protocol (Section 5.1)
排除标准
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). HIV infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their CD4 cell count is ≥200/mm³ and their viral load has been undetectable (i.e., HIV-RNA < 50 copies/mL).
- •History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- •Acute or unstable chronic conditions [clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions], as determined by medical history and clinical examination.
- •Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration prior to Visit 2 during the study.
- •History of test confirmed influenza infection within 180 days prior to study intervention administration.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study. • Up to 90 days prior to the study intervention administration: o For systemic corticosteroids: prednisone equivalent ≥20 mg/day for >14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. o Long-acting immune modifying drugs including, among others, immunotherapy (e.g., TNF inhibitors), monoclonal antibodies, antitumoral medication
- •For further exclusion criteria, kindly refer to the protocol (Section 5.2)
研究组 & 干预措施
Alpharix suspensie voor injectie in een voorgevulde spuit Trivalent griepvaccin (gefragmenteerd virion, geïnactiveerd)
干预措施: Alpharix suspensie voor injectie in een voorgevulde spuit Trivalent griepvaccin (gefragmenteerd virion, geïnactiveerd) (Drug)
Efluelda TIV-HD, suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain
干预措施: Efluelda TIV-HD, suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain (Drug)
结局指标
主要结局
•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29
•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29
Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.
Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.
次要结局
- • HI titers at Day 29 • HI seroconversion from baseline to Day 29
- • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29
研究者
EU GSK Clinical Trials Call Center
Scientific
GlaxoSmithKline Biologicals