A phase III, randomized, open study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicalsâ?? oral live attenuated human rotavirus (HRV) vaccine, Rotarix, when given as a two-dose primary vaccination, in healthy infants with no previous history of rotavirus illness or vaccination.

GlaxoSmithKline Biologicals0 个研究点目标入组 450 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals
入组人数: 450

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
•A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Birth weight >2000 g.

排除标准

•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines) (Day-29 to Day 1), or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of any chronic drug therapy to be continued during the study period.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3; with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations, according to the local immunization practice.
•Concurrently participating 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).
•History of confirmed RV GE.
•Previous vaccination against RV.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency [SCID] disorder) based on medical history and physical examination (no laboratory testing required).
•Uncorrected congenital malformation (such as Meckelâ??s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
•History of IS.
•Very prematurely born infants (born <=28 weeks of gestation).
•Hypersensitivity to latex.
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures.
•Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.
•ï?Fever is defined as temperature ï?³38.0Â°C/100.4Â°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla or the rectum.
•ï?Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
•GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).

研究者

发起方

GlaxoSmithKline Biologicals

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