Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 792
- 试验地点
- 1
- 主要终点
- To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
研究概览
简要总结
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.
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
- None
入排标准
- 年龄范围
- 60 Days 至 74 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 months (60 to 74 days) inclusive on the day of inclusion
- •Born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg
- •Informed consent form signed by the parent(s) or other legal representative
- •Able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion
- •Blood or blood-derived products received in the past
- •Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
- •Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
- •History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
- •Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- •Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current seizures
- •Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
研究组 & 干预措施
1
DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.
干预措施: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib (Biological)
3
Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age
干预措施: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed (Biological)
2
DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.
干预措施: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
时间窗: 1 Month post-dose 3
次要结局
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine(19 months post-dose 1)