NCT00259337已完成3 期
Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
研究概览
简要总结
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.
Safety:
This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 42 Days 至 56 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 42 to 56 days inclusive on the day of inclusion
- •Born at full term pregnancy (> 37 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 (first) trial vaccination
- •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 preceding the trial vaccination (except BCG and hepatitis B)
- •History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
- •Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current seizures
- •Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
结局指标
主要结局
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
时间窗: 19 months
次要结局
未报告次要终点
研究者
研究点 (1)
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