A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given to healthy infants at 2, 4 and 12 months of age. - DTPA-HBV-IPV=HIB-MENC-TT-003

GlaxoSmithKline Biologicals0 个研究点目标入组 480 人开始时间: 2010年1月11日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals
入组人数: 480

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•-A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
•-Born after a gestation period of 36 to 42 weeks inclusive.
•-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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•The following criteria should be checked at the time of study entry. If ANY exclusion
•criterion applies, the subject must not be included in the study:
•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. For corticosteroids, this will mean
•prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Child in care.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior
•to randomisation, or planned administration from randomisation to the end of the
•study with the exception of inactivated influenza vaccines. The administration of
•diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal,
•rotavirus and/or MenC vaccines is not allowed at any time during the study period
•but other vaccines are allowed during the period from one day after study Visit 3 to
•31 days before study Visit 4.
•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).
•Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib,
•pneumococcal, rotavirus and/or MenC vaccination or disease, including HBV
•vaccination at birth.
•History of seizures or progressive neurological disease.
•Subjects with history of intussusception or uncorrected congenital malformation of
•the gastrointestinal tract that would predispose for intussusception.
•Any confirmed or suspected immunosuppressive or immunodeficient condition,
•based on medical history and physical examination (no laboratory testing required).
•History of any reaction or hypersensitivity likely to be exacerbated by any
•component of the vaccine(s).
•Major congenital defects or serious chronic illness.
•The following condition is temporary or self-limiting, and a subject may be vaccinated
•once the condition has resolved if no other exclusion criteria is met:
•Current febrile illness (axillary temperature = 38.5 ºC or rectal temperature = 39.0°C)
•or other moderate to severe illness within 24 hours of study vaccine administration.
•Current gastrointestinal infection (diarrhoea, vomiting)

研究者

发起方

GlaxoSmithKline Biologicals

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