EUCTR2012-001481-16-Outside-EU/EEA进行中（未招募）不适用
A phase I, double-blind, randomised, placebo-controlled study to assess the reactogenicity and safety of two doses of GlaxoSmithKline Biologicals’ (GSK) oral live attenuated liquid human rotavirus (HRV) vaccine, when administered to healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination according to a 0, 1 month schedule in China. - Rota-074
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
- 50
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 who the investigator believed that their parents/ Legally Acceptable Representative(s) (LARs could) can and wouldwill comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- •A male or female infant of Chinese origin between, and including, 6 and 16 weeks (42–112 days) of age at the time of the first vaccination.
- •Written informed consent was obtained from the parents/LARs of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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 (drug or vaccine) other than the study vaccine 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 (for corticosteroids, this meant prednisone, > or equivalent to 0.5 mg/kg/day. Inhaled and topical steroids were allowed).
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the HRV vaccine or placebo except for the routine childhood vaccinations (i.e. DTP and OPV).
- •Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •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.
- •Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. The vaccine could be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.1°C as defined by the Chinese authorities). Temperature greater than or equal to this cut-off warranted deferral of the vaccination pending recovery of the subject.
- •History of confirmed RV GE.
- •GE within 7 days preceding the study vaccine or placebo administration (warranted deferral of the vaccination).
- •Previous vaccination with RV vaccine or planned to use during the study period.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
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