Evaluating the effectiveness of the 10-valent pneumococcal conjugate vaccine in preventing invasive pneumococcal disease among Vietnamese children under 5 years of age

Pasteur Institute in Ho Chi Minh City0 个研究点目标入组 1,000 人开始时间: 2020年12月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Case-patients: A 2-59 month-old child with clinically suspected invasive disease (including meningitis and respiratory infections with bacteremia or sepsis) will be eligible if all the following criteria are met:
•- Pneumococcus is isolated from his/her normal sterile body fluid (i.e., blood and CSF) taken as part of routine therapeutic practice.
•- A case-patient who the investigator believes that his/her parent(s) or Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol
•- Written informed consent obtained from the subject/from his/her parent(s) or LAR.
•Controls: At recruitment, controls are healthy children who are individually matched to case-patients by age intervals (2-<12, 12-<24, and 24-59 months) and commune where case-patients live before hospital admission. The age of a case-patient will be determined based on the culture-positive date. The age of a control will be determined at the time when the enrollment takes place.

•A child who meet one of the following criteria: (1) his/her parent (s) or LAR are unable or refuse to consent; (2) he/she have neither birth certificates nor hospital birth registries; (3) he/she have no immunization records; (4) he/she has participated in a PCV trial.

发起方