asopharyngeal pneumococcal carriage and immunogenicity with reduced and alternate dose schedule of pneumococcal conjugate vaccine in infancy.

KEM Hospital Research Centre0 个研究点目标入组 805 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy infants as established by medical history and clinical examination
•6-8 weeks of age at the time of enrolment.
•Written informed consent obtained from the parent(s) of infants
•Parent who intends to remain in the area with the child during the study period.

•Acute disease at the time of enrolment (temporary exclusion)
•Concurrent participation in another clinical trial during study period.
•Presence of significant malnutrition (weight-for-height z-score <-3SD median)
•Presence of significant systemic disorder as determined by medical history and/or physical examination
•Prior receipt of pneumococcal vaccine
•Known sensitivity or allergy to any components of the study vaccine
•Major congenital or genetic defect
•Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
•History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids.
•Any medical condition in the subject, which, in the judgment of the investigator, would interfere with protocol adherence or participantâ??s parentsâ?? ability to give informed consent.

发起方

KEM Hospital Research Centre