A phase IV, open-label, study to assess the antibody persistence in healthy 5-year-old children, previously vaccinated at 3, 5 and 11months of age with GSK Biologicals’ DTPa-HBV-IPV/Hib or DTPa-IPV/Hib vaccine, in study 105539 (10PN-PD-DIT-002). - DTPA-HBV-IPV-131

GlaxoSmithKline Biologicals0 个研究点目标入组 150 人开始时间: 2011年4月11日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•Subjects who had received 3 doses of Infanrix hexa or Infanrix-IPV/Hib in the study 10PN-PD-DIT-002 (105539).
•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
•A male or female subject aged 5 years at the time of study entry (from the 5th birthday until but excluding the 6th birthday).
•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: 150
•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

•Child in care.
•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).
•Use of any investigational or non-registered product (drug, vaccine or device) within 30 days prior to blood sampling.
•Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study 10PN-PD-DIT-002 (105539), with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
•Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) .
•Family history of congenital or hereditary immunodeficiency.

发起方