A Phase 2a Randomized, Observer-Blind, Study to Evaluate the Immunogenicity and Safety of mRNA-Based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Geometric Mean Titer (GMT) Of Antigen 1 Titer
研究概览
简要总结
The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults.
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
This is an observer-blind study.
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
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
- •Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
- •A male or female at least 18 YOA at the time of the screening.
- •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, 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.
- •Female participants of non-childbearing potential may be enrolled in the clinical study.
- •Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
- •Has practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and
- •Has a negative urine pregnancy test within 24 hours prior to the study intervention administration, and
- •Has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.
- •Body mass index (BMI) between18 kg/m^2 and 33kg/m^2.
排除标准
- •Where applicable, FDA toxicity grades will be exclusionary.
- •Current or chronic conditions related with EXC criteria
- •Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
- •History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
- •Hypersensitivity to latex.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •History of hypersensitivity or allergic reaction to any previous influenza vaccine.
- •History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- •History of or current suspicion of myocarditis or pericarditis or medical condition increasing such risks.
- •Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- •History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
- •Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
- •Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study.
- •Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration or planned administration within 14 days after study intervention administration.
- •Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration
- •Chronic administration of immune-modifying drugs.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
- •Administration of antitumoral medication during the period starting 90 days before the study intervention or planned administration during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
- •Any study personnel or their immediate dependents, family, or household members.
- •History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- •Participant is pregnant.
- •Participant is breastfeeding or will (re)start breastfeeding during the study.
研究组 & 干预措施
Flu mRNA_1_YA
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1.
干预措施: Flu mRNA (Formulation B1) (Biological)
Flu mRNA_3_YA
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
干预措施: Flu mRNA (Formulation B3) (Biological)
Flu mRNA_4_YA
Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
干预措施: Flu mRNA(Formulation A) (Biological)
Comparator_1_YA
Eligible YA participants receive a single dose of comparator 1 at Day 1.
干预措施: Comparator 1 (Combination Product)
Comparator_2_YA
Eligible YA participants receive a single dose of comparator 2 at Day 1.
干预措施: Comparator 2 (Combination Product)
Flu mRNA_1_OA
Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1.
干预措施: Flu mRNA (Formulation B1) (Biological)
Flu mRNA_3_OA
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
干预措施: Flu mRNA (Formulation B3) (Biological)
Flu mRNA_4_OA
Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
干预措施: Flu mRNA(Formulation A) (Biological)
Comparator_1_OA
Eligible OA participants receive a single dose of comparator 1 at Day 1.
干预措施: Comparator 1 (Combination Product)
Comparator_2_OA
Eligible OA participants receive a single dose of comparator 3 at Day 1.
干预措施: Comparator 3 (Combination Product)
结局指标
主要结局
Geometric Mean Titer (GMT) Of Antigen 1 Titer
时间窗: At Day 29
Geometric Mean Increase (GMI) of Antigen 1 Titer
时间窗: From Day 1 to Day 29
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
时间窗: From Day 1 to Day 29
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
时间窗: At Day 1 and Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
时间窗: From 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: From Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4 °F regardless the location of measurement.
Number of Participants with Unsolicited AEs
时间窗: From 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: From Day 1 to Day 181 (study end)
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: From Day 1 to Day 181 (study end)
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: From Day 1 to Day 181 (study end)
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.
Number of Participants with any Laboratory abnormalities
时间窗: From Day 1 to Day 29
次要结局
- GMT Ratio of Antigen 2 Titer(At Day 29)
- GMI of Antigen 2 Titer(From Day 1 to Day 29)
- Percentage of Participants with Antigen 2 SCR(From Day 1 to Day 29)