NCT01519713已完成3 期
Immunogenicity and Safety of a Single Dose of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
研究概览
简要总结
This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan.
Primary Objective:
- To describe the seroprotection rate [% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age
Secondary Objectives:
- To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age
- To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.
详细描述
All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 through 55 years on the day of inclusion
- •For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of age will provide assent and subjects 12 to 19 years of age will provide written assent form.
- •Able to attend all scheduled visits and to comply with all trial procedures
- •For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
排除标准
- •Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •History of meningococcal diseases, 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
- •Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •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, which might interfere with assessment of the immune response
- •Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two 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
- •Ineligible according to the investigator's clinical judgment
- •Known pregnancy, or suspected pregnancy or a positive (serum and/or urine) pregnancy test
- •Currently breast feeding a child
- •Known thrombocytopenia, contraindicating intramuscular (IM) vaccination
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •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 employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
- •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
- •History of Guillain-Barré Syndrome.
结局指标
主要结局
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
时间窗: 28 Days post-vaccination
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
次要结局
- Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine(28 Days post-vaccination)
- Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.(28 Days post-vaccination)
- Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine(Days 0 and 28 post-vaccination)
- Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine(28 Days post-vaccination)
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine(Day 0 up to Day 28 post-vaccination)
研究者
研究点 (3)
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