Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.
研究概览
简要总结
Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study.
Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.
详细描述
Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known cause of persistent cough primarily affecting infants and young children. Repeated administration of the vaccine is often needed to reduce the disease burden and control its transmission. At this time, no data are available on the epidemiology of pertussis in adolescents and adults in Kazakhstan.
The aim of the present study is to estimate the prevalence of pertussis infection in different age groups in Kazakh children and adolescents using the anti-pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis infection or vaccination. The serosurvey will be conducted in 4 different regions: Aktobe, Karaganda, Taldykorgan, and Shymkent.
Participants (≥ 10 years & < 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.
Upon obtaining informed consent for participant parent/guardian, the study coordinator will complete an investigation form (IF) for each participant and collect serum samples. The specimens will be coded by a unique participant number and delivered to the laboratory in charge of the assay. The specimens will be used for serological analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-18 years old
- •Informed consent obtained from parents or guardian(s) and assent from patient.
- •Enrollment following a visit at the study center.
- •Documented vaccination history
排除标准
- •Inclusion criteria:
- •10-18 years old
- •Informed consent obtained from parents or guardian(s) and assent from patient.
- •Enrollment following a visit at the study center.
- •Documented vaccination history
- •Exclusion criteria:
- •≤10 years and ≥ 19 years
- •Pertussis immunization during the last 12 months
- •No informed consent obtained from one parent or guardian.
- •Immunocompromised patients
- •Patients with acute infectious diseases
结局指标
主要结局
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.
时间窗: 25.01.2021-17.10.2021
To estimate the prevalence of recent infection Bp infection, using increased anti-PT antibody levels as markers of Bp infection in the serology test.
次要结局
- The prevalence of recent Bp infection in the test in the selected population sample stratified by demographic and socio-economic criteria, vaccination history, and risk of infection.(25.01.2021-17.10.2021)