Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines
研究概览
简要总结
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
Immunogenicity
- To assess pre- and post-primary series
- To assess pre- and post-booster series.
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
- 50 Days 至 71 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator
- •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 corticosteroid therapy
- •Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 (except BCG) in the 4 weeks preceding the first trial vaccination
- •Vaccination planned in the 4 weeks following trial vaccination
- •History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- •Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
- •Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
- •Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of seizures
- •Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.
研究组 & 干预措施
Group 1: DTaP-IPV-Hep B-PRP-T
Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T); One dose each at 2, 3, and 4 months of age.
干预措施: DTaP-IPV-HB-PRP~T vaccine (Biological)
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC
Participants will receive 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
干预措施: DTaP-IPV//PRP~T combined (Biological)
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC
Participants will receive 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
干预措施: Hepatitis B vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines
时间窗: Day 90 post first dose
Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.
次要结局
- Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®(Day 90 post first dose)
- Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®(Day 90 post first dose)
- Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®(Day 0 (pre-vaccination) and Day 30 post-dose 3)
- Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®(Day 0 to Day 7 post any dose)
- Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®(Day 90 (30 Days post-dose 3))