EUCTR2013-004194-27-Outside-EU/EEA进行中（未招募）不适用
A Phase III, randomized, multicenter study, double-blind for the immunogenicity and consistency evaluation of 3 lots of GSK Biologicals’ Haemophilus influenzae type b (Hib) conjugate vaccine and single blind and controlled for the evaluation of safety and immunogenicity of GSK Biologicals’ Hib vaccine 208108 compared to the monovalent Hib vaccine ActHIB and open for comparison with the combined DTPa-IPV-Hib vaccine Pentacel when administered to healthy infants at 2, 4, 6 and 15-18 months of age with recommended co-administrations at separate sites. - HIB-097
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,009
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects for whom the investigator believes that their parent/Legally Acceptable Representative can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the subject’s parent/LAR.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of minimum 36 weeks.
- •Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4009
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product other than the study vaccine 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.
- •Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
- •Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment. A temperature greater than or equal to this cut-off warrants deferral of the vaccination pending recovery of the subject.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrent participation in another clinical study, up to 30 days prior to study entry or 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.
- •Child in care.
- •History of intussusception.
- •History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
- •History of Severe Combined Immunodeficiency Disease (SCID).
研究者
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