A Translational Phase I, Randomized, Parallel-group, Multi-arm Study to Evaluate Safety and Immunogenicity of an Influenza Vaccine Formulation Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Number of participants with unsolicited adverse events
研究概览
简要总结
Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, compared to formulations containing a single strain from each influenza virus subtype.
Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose. Adults ≥ 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose.
Enrollment of participants in Stage 2 will occur after review of, and be guided by, safety and immunogenicity results from Stage 1. The study duration will be approximately 3 weeks.
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
Modified double-blind (observer-blind; blinded for participants and sites, except for those preparing/administering study intervention, and for the Sponsor, except for dedicated Sponsor staff who will be unblinded for interim analysis
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 to 49 years (Stage 1) or 60 years of age and older (Stage 2) on the day of inclusion
- •Participants who are healthy as determined by medical evaluation including medical history and physical examination, if deemed necessary
- •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 post-menopausal for at least 1 year, or surgically sterile OR
- •Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to study intervention administration until at least 3 weeks after study intervention administration
- •A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before the first dose of study intervention.
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)
- •History of clinically- or laboratory-confirmed diagnosis of influenza infection in the last 12 months
- •Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •Self-reported or prior documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
- •Body mass index of 40 or higher
- •Current or past diagnosis, personal or in the family, of Guillain-Barré syndrome
- •Have known or recently active (within 12 months) neoplastic disease or a current or past diagnosis of any hematologic malignancy
- •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 3 weeks (approximately 21 days, or until the end of study participation) following study intervention administration
- •Previous vaccination against influenza (in the year 2024) with an investigational or marketed vaccine. In the case of adults ≥ 60 years of age (Stage 2 of the study), previous vaccination within 6 months' time period will apply.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •Any change in chronic prescription medication or change in medication dose or dosage in the 60 days prior to enrollment
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Group 1 (Stage 1)
Trivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old
干预措施: Trivalent-Darwin influenza vaccine (Biological)
Group 2 (Stage 1)
Augment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old
干预措施: Augment-Tasmania influenza vaccine (Biological)
Group 3 (Stage 1)
TIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old
干预措施: TIV-2X Darwin influenza vaccine (Biological)
Group 4 (Stage 1)
Trivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old
干预措施: Trivalent-Tasmania influenza vaccine (Biological)
Group 5 (Stage 2)
Trivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older
干预措施: Trivalent-Darwin influenza vaccine (Biological)
Group 6 (Stage 2)
Augment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older
干预措施: Augment-Tasmania influenza vaccine (Biological)
Group 7 (Stage 2)
TIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older
干预措施: TIV-2X Darwin influenza vaccine (Biological)
Group 8 (Stage 2)
Trivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older
干预措施: Trivalent-Tasmania influenza vaccine (Biological)
结局指标
主要结局
Number of participants with unsolicited adverse events
时间窗: Throughout the study, approximately 3 weeks
Adverse events other than solicited reactions
Number of participants with immediate adverse event
时间窗: Within 30 minutes after vaccination
Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered
Number of participants with solicited systemic reactions
时间窗: Within 7 days after vaccination
Adverse reactions prelisted in the participant diary
Number of participants with serious adverse events
时间窗: Throughout the study, approximately 3 weeks
SAEs occurring throughout the study
Number of participants with solicited injection site reactions
时间窗: Within 7 days after vaccination
Adverse reactions prelisted in the participant diary
Number of participants with adverse events of special interest (AESIs)
时间窗: Throughout the study, approximately 3 weeks
AESIs occurring throughout the study
次要结局
- 2-fold rise in virus neutralization titers(From day 1 to day 22)
- Obtained hemagglutination inhibition antibody titers(Day 1 and day 22)
- Obtained virus neutralization antibody titers(Day 1 and day 22)
- Seroconversion based on hemagglutination inhibition antibody titer(Day 1 and day 22)
- Seroprotection based on hemagglutination inhibition antibody titer(Day 1 and day 22)
- Individual hemagglutination inhibition titers ratio(Day 1 and day 22)
- Individual virus neutralization titers ratio(Day 1 and day 22)
- 4-fold rise in virus neutralization titers(From day 1 to day 22)