NCT00753649已完成4 期
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
研究概览
简要总结
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
详细描述
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Healthy subjects as established by medical history before entering into the study.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Major congenital defects or serious chronic illness.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
结局指标
主要结局
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
时间窗: One month after (POST) Dose 3.
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
次要结局
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31 day (Days 0-30) post vaccination)
- Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)(One month after (POST) Dose 3.)
- Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL(One month after (POST) Dose 3.)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period up to Last subject last visit on 03/12/2013)
- Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL(One month after (POST) Dose 3.)
- Anti-PRP Antibody Concentrations(One month after (POST) Dose 3.)
- Anti-HBs Antibody Concentrations(One month after (POST) Dose 3.)
研究者
研究点 (4)
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