Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- Number of participants reporting immediate adverse events (AEs)
研究概览
简要总结
The primary objectives of this study are:
- To describe the safety profile of each of the investigational vaccine formulations for all participants
- To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
- To evaluate the dose response to vaccine components
- To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations
详细描述
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
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)
入排标准
- 年龄范围
- 19 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals born in Canada and vaccinated with a combination vaccine in accordance with the National Immunization Program (NIP).
- •Aged ≥ 19 years and < 22 years on the day of inclusion.
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 3 months after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- •Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or after any study vaccination except for influenza vaccination only, which may be received at least 2 weeks before or 2 weeks after any study vaccination.
- •History of autoimmune disorder.
- •History of cardiovascular disorder.
- •History of Guillain-Barré syndrome.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- •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).
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
- •Laboratory-confirmed/self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1: Investigational Product (IP) Formulation A
IP Formulation A administration, participation in Stage 1 and Stage 2
干预措施: Investigational Tdap vaccine Formulation A (Biological)
Group 2: IP Formulation A
IP Formulation A administration, participation in Stage 1
干预措施: Investigational Tdap vaccine Formulation A (Biological)
Group 3: IP Formulation B
IP Formulation B administration, participation in Stage 1 and Stage 2
干预措施: Investigational Tdap vaccine Formulation B (Biological)
Group 4: IP Formulation B
IP Formulation B administration, participation in Stage 1
干预措施: Investigational Tdap vaccine Formulation B (Biological)
Group 5: IP Formulation C
IP Formulation C administration, participation in Stage 1 and Stage 2
干预措施: Investigational Tdap vaccine Formulation C (Biological)
Group 6: IP Formulation C
IP Formulation C administration, participation in Stage 1 and Stage 2
干预措施: Investigational Tdap vaccine Formulation C (Biological)
Group 7: IP Formulation D
IP Formulation D administration, participation in Stage 1 and Stage 2
干预措施: Investigational Tdap vaccine Formulation D (Biological)
Group 8: Tdap
TdaP administration, participation in Stage 1 and Stage 2
干预措施: Licensed Tdap vaccine (Biological)
Group 9: Tdap
TdaP administration, participation in Stage 1
干预措施: Licensed Tdap vaccine (Biological)
结局指标
主要结局
Number of participants reporting immediate adverse events (AEs)
时间窗: Within 30 minutes post-vaccination
AEs, including those related to the product administered
Number of participants reporting unsolicited AEs
时间窗: Within 30 days post-vaccination
AEs other than solicited reactions
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
时间窗: Within 60 days post-vaccination
Haematological and biochemical laboratory parameters
GMCs of anti-tetanus toxoid immunoglobulins
时间窗: From Day 0 to Day 360
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Number of participants reporting serious adverse events (SAEs)
时间窗: Up to 12 months post-vaccination
SAEs, including adverse event of special interest (AESIs)
Number of participants reporting medically attended adverse events (MAAEs)
时间窗: Up to 12 months post-vaccination
MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
时间窗: From Day 0 to Day 360
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Geometric means of antigen-specific cells
时间窗: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
Number of participants reporting solicited injection sites or systemic reactions
时间窗: Within 7 days post-vaccination
Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants reporting adverse events of special interest (AESIs)
时间窗: Up to 12 months post-vaccination
AESIs are reported until the end of the safety follow-up period
GMCs of anti-diphtheria toxoid immunoglobulins
时间窗: From Day 0 to Day 360
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Percentages of antigen-specific cells
时间窗: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
次要结局
未报告次要终点