EUCTR2005-002352-18-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of safety and immunogenicity of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age. - Hib-MenCY-TT-009 & Hib-MenCY-TT-010
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
- 4,441
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 parents/guardians 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 or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after 36 weeks gestation.
- •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.
- •Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4441
- •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 (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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
- •Any confirmed or suspected immunosuppressive or immuno-deficient condition based on medical history and physical ex-amination (no laboratory testing is required).
- •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.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrent participation 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 (pharmaceutical product or device).
- •Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be adminis-tered M-M-R II and Varivax if any of these criteria apply:
- •History of measles, mumps, rubella or varicella.
- •Previous vaccination against measles, mumps, rubella or varicella.
- •Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- •Patients receiving immunosuppressive therapy.
- •Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- •Individuals with primary and acquired immunodeficiency states.
- •Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •Individuals with active tuberculosis.
- •Acute disease at time of booster vaccination.
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