Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children

GlaxoSmithKline Biologicals0 个研究点目标入组 282 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
•Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•For primed subjects:
•Completion of the full vaccination course in study NCT00814710.
•9-18 months of age at the time of randomization.
•Group A: 9-18 months of age at the time of booster vaccination.
•Group B: 15-18 months of age at the time of booster vaccination.
•For unprimed subjects (Group C):
•Enrolled in study NCT00814710.
•12-18 months of age at the time of first vaccination.

•Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
•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.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
•Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
•Administration of any pneumococcal vaccine since the end of study NCT00814710.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of reactions or allergic disease 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.

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