Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
研究概览
简要总结
This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.
Primary Objective:
- To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents
Secondary Objective:
- To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.
详细描述
All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 11 or 12 years on the day of inclusion
- •Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
- •Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (DT) vaccination
- •Able to attend all scheduled visits and to comply with all trial procedures
- •For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
排除标准
- •Any conditions or diseases which, in the opinion of the investigator
- •would pose a health risk to the subject
- •or might interfere with the ability to participate fully in the study
- •or might interfere with evaluation of the vaccine
- •or would otherwise make participation inappropriate according to the investigator's clinical judgment
- •History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
- •Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
- •Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
- •Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
- •Planned receipt of any vaccine during the trial period
- •Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
- •At high risk for diphtheria, tetanus or pertussis infection during the trial
- •Known pregnancy, or a positive urine pregnancy test
- •Currently breastfeeding a child
- •Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.
结局指标
主要结局
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
时间窗: Day 28 post-vaccination
Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
时间窗: Day 28 post-vaccination
Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \> 2.56 IU/mL. Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \> 2.7 IU/mL.
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
时间窗: Day 28 post-vaccination
Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but \< 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
次要结局
未报告次要终点