EUCTR2013-003535-30-GB进行中（未招募）1 期
A Phase III, double blind, randomized, comparative study of the safety and immunogenicity of GSK Biologicals’ Varilrix HSA-free varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKAH-193
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,220
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)/ 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, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
- •Written informed consent obtained from the par-ent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •Subjects in stable health as determined by investigator’s clinical examination and assessment of subject’s medical history.
- •Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1220
- •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 vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period.
- •Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
- •Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immuno-suppressive and immune-modifying drugs during the entire study.
- •?-For corticosteroids, this will mean prednisone =0.5 mg/kg/day or equivalent.
- •?-Inhaled and topical steroids are allowed.
- •Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures.
- •Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this period, non-study inactivated vaccines can be administered as per standard of care.
- •Administration of immunoglobulins and/or any blood prod-ucts during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study.
- •History of varicella or zoster.
- •Known exposure to varicella/zoster during the period start-ing within 30 days prior to first study vaccination.
- •Previous vaccination against varicella.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Subjects with blood dyscrasias, leukemia, and lymphomas of any type.
- •A family history of congenital or hereditary immunodefi-ciency
- •History of allergic disease or reactions likely to be exacer-bated by any component of the vaccines, including hyper-sensitivity to neomycin or latex.
- •Major congenital defects or serious chronic illness.
- •Acute disease and/or fever at the time of enrolment.
- •--Fever is defined as temperature =38. 0°C/100.4°F by any age appropriate route.
- •--Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Active untreated tuberculosis based on medical history.
- •Any other condition which, in the opinion of the investigator, prevents the child from participating in the study
研究者
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