An open, multicentre, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3 and 4 months of age and DTPa-HBV-IPV/Hib vaccine (INFANRIX HEXA™) administered at 5 months of age, as primary vaccination course, followed by administration of GSK Biologicals’ DTPa-IPV/Hib vaccine at 18 months of age in healthy infants who received hepatitis B vaccine at birth and at one month of age. - DTPa-HBV-IPV-100

GlaxoSmithKline Biologicals0 个研究点目标入组 702 人开始时间: 2015年2月17日最近更新: 2015年2月23日

试验速览

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•Subjects must have been enrolled in the Rota-028 study.
•Subjects for whom the investigator believes that their par-ents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guard-ian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Subjects should have received two doses of hepatitis B vac-cine: at birth and at approximately one month of age.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 702
•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

•Chronic administration of immunosuppressants or other immune-modifying drugs during the study period.
•Planned administration/ administration of a vaccine not fore-seen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
•Any confirmed or suspected immunosuppressive or immu-nodeficient condition, including human immunodeficiency virus infection.
•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.
•History of any neurologic disorders or seizures.
•Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness such as diar-rhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5 °C.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

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