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临床试验/NCT02112890
NCT02112890已完成不适用

Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 1,603 人开始时间: 2014年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,603
试验地点
1
主要终点
Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV

研究概览

简要总结

This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.

详细描述

A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) will be selected from the total population that participated in the Encuesta Nacional de Salud y Nutrición (ENSANUT) 2012 in Mexico.

Data (through structured questionnaires and interviews) and stored serum samples of the selected subjects obtained from the ENSANUT 2012 will be used in this study. A subset database will be designed by the National Institute of Public Health (NIPH) for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in this database.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent for the ENSANUT 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (LAR) of the subject.
  • A male or female between and including 10 and 25 years of age, who previously participated in the ENSANUT 2012 in Mexico.

排除标准

  • Information required for the study is not available or incomplete.
  • Inadequate or insufficient serum sample to perform the laboratory tests for this study.
  • Serum sample is wrongly identified.

结局指标

主要结局

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV

时间窗: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HBV (Hepatitis B core antibody [anti-HBc], Hepatitis B surface antigen [HBsAg]) and Hepatitis B surface antibody (anti-HBs)

时间窗: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies

时间窗: During the study (approximately 12 months)

次要结局

  • Assesment of the difference in HAV, HBV and B. pertussis seropositivity rates among - Socioeconomic strata, - Regions, - Age groups, - Genders, - Risk groups, - Vaccination status for B. pertussis (if available)(During the study (approximately 12 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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