An open, multicentric, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants. - DTPa-IPV-052

GlaxoSmithKline Biologicals0 个研究点目标入组 4,500 人2015年6月9日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Healthy volunteers (Primary immunization of healthy infants at 3, 4 and 5 months of age with a booster dose at 18 months of age, against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b diseases).
发起方: GlaxoSmithKline Biologicals
入组人数: 4500
状态: 进行中（未招募）
最后更新: 10年前

暂无简介。

注册库

who.int

开始日期

2015年6月9日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Subjects must have been enrolled in the Rota\-028 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 guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2590
•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

•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen 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 immunodeficient condition, including human immunodeficiency virus (HIV) 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. (Acute disease is defined as the presence of a moderate or severe illness with or without fever.) All vaccines can be administered to persons with a minor illness such as diarrhoea, 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.