NCT01061541已完成2 期
A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- anti-PRP antibody concentration above a protocol defined cut-off value.
研究概览
简要总结
In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.
Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians 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 8 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks.
- •Born to a mother proven seronegative for HBsAg.
排除标准
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
- •Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) 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 since birth.
- •Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
- •History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
结局指标
主要结局
anti-PRP antibody concentration above a protocol defined cut-off value.
时间窗: One month after the third dose of the primary vaccination course.
次要结局
- Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens(Before the first dose of the primary vaccination course)
- Occurrence of solicited symptoms(During the 4-day follow-up period after each dose)
- anti-PRP antibody concentration(Before and one month after the plain PRP challenge dose.)
- anti-tetanus antibody concentration(One month after the third dose of the primary vaccination course)
- anti-HBs antibody concentration(One month after the third dose of the primary vaccination course)
- anti-diphtheria antibody concentration(One month after the third dose of the primary vaccination course)
- anti-Bordetella pertussis (BPT) antibody concentration(One month after the third dose of the primary vaccination course)
- Vaccine response to Bordetella pertussis antigen.(One month after the third dose of the primary vaccination course)
- Occurrence of unsolicited symptoms(During the 31-day follow-up period after each dose)
- Occurrence of serious adverse events(Over the full course of the study)
研究者
研究点 (2)
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