NCT00254969已完成3 期
Immunogenicity and Safety of Pentaxim in South African Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 212
- 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
The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.
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
- 24 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged < 24 hours on the day of inclusion
排除标准
- •At visit 01 (screening)
- •Illness at a stage that could interfere with trial conduct or completion.
- •Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
- •Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
- •Planned participation in another clinical trial during the present trial period
- •Blood or blood-derived products received since birth.
- •Mother known as seropositive to HIV or hepatitis B.
- •Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current seizures at visit 02 (first study vaccination)
- •Participation in another clinical trial preceding the first trial vaccination
- •Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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.
- •Any vaccination preceding the first trial vaccination (except BCG)
- •History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
- •Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination
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-vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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