A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 8
- 主要终点
- To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
研究概览
简要总结
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.
Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®
Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.
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
- 42 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 42 to 89 days inclusive on the day of inclusion.
- •Born at full term of pregnancy (>37 weeks).
- •Informed consent form signed by the parent(s) or legally authorized representative.
- •Able to attend all scheduled visits and to comply with the study procedures.
- •Parent or legally authorized representative has access to a telephone.
- •Parent or legally authorized representative able to read and write in English or French.
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.
- •Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- •Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- •Chronic illness that could interfere with trial conduct or completion.
- •Received blood or blood-derived products since birth.
- •Any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination).
- •Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, hepatitis B, or pneumococcal conjugate vaccines.
- •Coagulation disorder contraindicating IM vaccination.
- •Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- •Developmental delay or neurological disorder.
- •Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- •Documented Hepatitis B surface Antigen (HBsAg) seropositivity in the child or his/her mother.
- •History of Hib, hepatitis B, diphtheria, tetanus, pertussis or poliovirus disease.
结局指标
主要结局
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
时间窗: 14 Months
次要结局
未报告次要终点