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临床试验/NCT04725669
NCT04725669Unknown不适用

Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents

University Hospital for Infectious Diseases, Croatia2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,500
试验地点
2
主要终点
Waning of vaccine-induced immunity

研究概览

简要总结

Pertussis is a vaccine preventable disease caused by Bordetella pertussis. Older children and adolescents with pertussis continue to be a significant source of infection for incompletely vaccinated infants who are in harm for developing severe disease. The primary objective of our study is to estimate the duration of protection elicited by the current vaccination schedule against pertussis in Croatia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children and adolescents from 6 to 18 years of age treated through Emergency room and/or Day hospital of Pediatric Infectious Diseases Department at UHID;
  • appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to Croatian NIP proven by insight in the Vaccination Record Card
  • written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old.

排除标准

  • children under 6 years
  • children and adolescents with acute respiratory symptoms
  • children and adolescents with pertussis-like illness within 12 months
  • children and adolescents with unknown, uncompleted or irregular vaccination record
  • inpatients
  • children and adolescents with immunodeficiencies

结局指标

主要结局

Waning of vaccine-induced immunity

时间窗: 1 day

Number of Participants In Each Specific Age Group With Negative Pertussis Toxin IgG Antibody Titre Measured by ELISA IgG Testkit

次要结局

  • Seroprevalence(up to 6 months)

研究者

发起方
University Hospital for Infectious Diseases, Croatia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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