NCT00255021已完成4 期
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Immunogenicity: To provide information concerning the immune response of the 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 Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
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
- 2 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 53 to 70 days inclusive on the day of inclusion
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 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.
- •Blood or blood-derived products received in the past.
- •Mother known as seropositive to HIV or hepatitis B
- •Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
- •History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
- •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 (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
Immunogenicity: To provide information concerning the immune response of the 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)
Loading locations...
相似试验
已完成
3 期
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected InfantsPolioHuman Immunodeficiency Virus InfectionHepatitis BTetanusDiphtheriaPertussisNCT02817451Sanofi Pasteur, a Sanofi Company53
已完成
3 期
Immunogenicity and Safety of Pentaxim™ in an Indian PopulationPolioHaemophilus InfectionsTetanusDiphtheriaPertussisNCT00259337Sanofi226
已完成
3 期
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After BirthPoliomyelitisHaemophilus Influenzae Type bHepatitis BPertussisTetanusDiphtheriaNCT02428491Sanofi Pasteur, a Sanofi Company354
已完成
3 期
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at BirthPoliomyelitisInvasive Hib InfectionsHepatitis BWhooping CoughTetanusDiphtheriaNCT01948193Sanofi Pasteur, a Sanofi Company177
已完成
3 期
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed InfantsHaemophilus Influenzae Type b InfectionPoliomyelitisPertussisHepatitis BTetanusDiphtheriaNCT02094833Sanofi Pasteur, a Sanofi Company310