EUCTR2013-003459-39-Outside-EU/EEA进行中（未招募）不适用
A phase IIIb, open, randomized, controlled, multicenter study to assess the co-administration of Rotarix (GlaxoSmithKline Biologicals’) with Hib-MenCY-TT (GlaxoSmithKline Biologicals’ Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) at 2 and 4 months of age, the co-administration of Prevnar 13 (Pfizer) with Hib-MenCY-TT at 2, 4 and 6 months of age and the co-administration of Prevnar 13 and Havrix (GlaxoSmithKline Biologicals’) with Hib-MenCY-TT at 12 to 15 months of age. - 112931
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
- 600
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’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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 parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born full-term.
- •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 enrolment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 602
- •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
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.
- •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus disease.
- •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. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- •Major congenital defects or serious chronic illnesses.
- •History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.
- •Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.
- •Acute disease and/or fever at the time of enrolment.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
研究者
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