A phase IV, open-label, multicentre, non-comparative study to assess reactogenicity and safety of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and DTPa-vaccine InfanrixTM in frame of three-doses primary immunization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation. - IPV-020 PMS

GlaxoSmithKline Biologicals0 个研究点目标入组 400 人开始时间: 2015年5月20日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female aged 3 months including at the time of the vaccination.
•Written informed consent obtained from the parent of the subject.
•Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don’t have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis according to the list of contraindications stated in me-thodical guidance 3.3.1.1095-02 Medical contraindications and prophylactic vaccination by National Calendar of Immunisations” and Instructions on medical use of PoliorixTM and InfanrixTM vaccines.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 400
•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

•Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs from birth.
•Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.
•Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product.
•Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.
•Medical history of convulsions and progressive neurological disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•Chronic diseases and serious congenital defects.
•Acute disease at the time of enrolment.

发起方