NCT00313911已完成3 期
Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,133
- 试验地点
- 2
- 主要终点
- Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
研究概览
简要总结
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Days 至 71 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 months old infants on the day of inclusion
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
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
- •Subjects with congenital or acquired immunodeficiency in the child's surrounding
- •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 since birth
- •Any vaccination in the 4 weeks preceding the first trial vaccination
- •Vaccination planned in the 4 weeks following the trial vaccination
- •Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- •Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
- •Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
- •Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- •History of seizures
- •Febrile or acute illness on the day of inclusion.
研究组 & 干预措施
Group 1: DTaP-IPV-Hep B-PRP-T
Experimental
干预措施: DTaP-IPV-HB-PRP~T (Biological)
Group 2: Tritanrix-Hep B/Hib™+OPV
Active Comparator
干预措施: Tritanrix-HepB/Hib (Biological)
结局指标
主要结局
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
时间窗: Day 0 up to Day 7 post-injection
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
次要结局
- Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo(Day 30 post-dose 3)
- Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo(Day 30 post-dose 3)
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination(Day 0 up to Day 7 Post-injection)
研究者
研究点 (2)
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