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临床试验/NCT06638333
NCT06638333已完成不适用

Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old

Tam Anh Research Institute3 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
800
试验地点
3
主要终点
Prevalence of pneumococcal carriage in the nasopharynx in children from 6 months to 5 years old in the Vietnamese community

研究概览

简要总结

This observational study is designed as a cross-sectional survey of children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh City for vaccination services.

After getting the informed consent form from a parent/guardian for their child(s) to participate in the study, nasopharyngeal swab sample will be taken. His/her guardian will be interviewed face-to-face with information related to epidemiological characteristics, nutritional status, child's birth history, hospitalization history, vaccination history, recent antibiotic usage, breastfeeding time, and environmental and lifestyle factors.

The goal is to document the burden and risk factors of pneumococcal infections in the community of healthy Vietnamese children. The main questions it aims to answer are:

  • What is the prevalence of pneumococcus in healthy children?
  • What is the distribution of pneumococcus serotypes in the community of healthy Vietnamese children?
  • What are risk factors of pneumococcus infection in the community of healthy Vietnamese children?

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 6 months and 5 years

排除标准

  • Children with chronic diseases (including immunologic diseases, neoplastic disorders, renal, cardiac, hepatic, or hematologic diseases, broncho dysplasia, Down syndrome, chronic otitis media with effusion)
  • Children with acute/chronic upper or lower respiratory tract infection
  • Children have used antibiotics within 1 week prior to entering the study

研究组 & 干预措施

Children between 6 months and 5 years

结局指标

主要结局

Prevalence of pneumococcal carriage in the nasopharynx in children from 6 months to 5 years old in the Vietnamese community

时间窗: Day 0 after recruitment

Pneumococcal prevalence in children by age group, sex and geographical area

Serotype distribution of pneumococcal strains in Vietnamese children from 6 months to 5 years old in the community

时间窗: Day 0 after recruitment

The number of carrier individuals by serotype will be determined for age group, sex and geographical area

次要结局

  • Risk factors associated with pneumococcal carriage(Day 0 after recruitment)

研究者

发起方
Tam Anh Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (3)

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