Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
研究概览
简要总结
This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents.
The purposes of this study are as follows:
- To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies
- To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301
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
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 11 or 12 years on the day of injection
- •Received 3 or 4 doses of DTaP vaccine
排除标准
- •History of pertussis, diphtheria, tetanus
- •History of anaphylaxis to vaccine components
- •Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system
- •Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection
研究组 & 干预措施
BK1301
干预措施: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) (Biological)
DT toxoid
干预措施: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) (Biological)
结局指标
主要结局
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
时间窗: pre-vaccination and 28-42 days after vaccination
Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer \< 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
时间窗: pre-vaccination and 28-42 days after vaccination
Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
次要结局
- Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies(28-42 days after vaccination)
- Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies(pre vaccination and 28-42 days after vaccination)
- Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values(28-42 days after vaccination)
- Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values(28-42 days after vaccination)
- Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies(pre vaccination and 28-42 days after vaccination)
- Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies(28-42 days after vaccination)
- Percentage of Participants With Adverse Events(28-42 days following vaccination)