NCT00329901已完成3 期
A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years
Novartis Vaccines14 个研究点 分布在 1 个国家目标入组 1,072 人开始时间: 2006年4月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,072
- 试验地点
- 14
- 主要终点
- Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
研究概览
简要总结
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female 11-25 years old healthy subjects;
- •who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry
排除标准
- •previous ascertained or suspected disease caused by N. meningitidis
- •previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- •serious acute, chronic or progressive disease
- •history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
- •known or suspected impairment/alteration of immune function, either congenital or acquired
结局指标
主要结局
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
时间窗: 1 month after vaccination (Day 29)
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
次要结局
- The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo(Day 1-7 after any vaccination)
- Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo(Day 1-7 after any vaccination)
- Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo(Throughout the study (Day 1 to Day 181))
- Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
- Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo(1 month after vaccination (Day 29))
研究者
研究点 (14)
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