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临床试验/NCT01160081
NCT01160081已完成不适用

Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 3,658 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,658
试验地点
1
主要终点
Anti-HSV seropositivity status (defined as the percentage of subjects with anti-HSV 1 and 2 titers >= assay cut-off): Subjects with anti-HSV antibody titers >= assay cut-off

研究概览

简要总结

The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.

详细描述

In order to document the epidemiological changes in the sero-prevalence of Hepatitis A, Human simplex virus (1 and 2), Varicella-Zoster virus and Cytomegalovirus infections, we propose to conduct a population based, seroprevalence, cross-sectional study, in Mexico. This will allow the identification of susceptible populations, which in turn, will serve as evidence for the elaboration of recommendations for the prevention of Hepatitis A, Human simplex virus, Varicella-Zoster virus and Cytomegalovirus infection in the region.

This study was conducted using data and serum samples from a random sample of subjects that participated in the 2006 National Health and Nutrition Survey.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
1 Year 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent

排除标准

  • Information required for the study is not available or incomplete.
  • Inadequate or insufficient serum sample to detect viral agents required for the study.
  • Serum sample wrongly identified.

结局指标

主要结局

Anti-HSV seropositivity status (defined as the percentage of subjects with anti-HSV 1 and 2 titers >= assay cut-off): Subjects with anti-HSV antibody titers >= assay cut-off

时间窗: 6 to 10 months from study initiation

Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.

时间窗: 6 to 10 months from study initiation

Anti-Pertussis Toxin seropositivity status for IgG and IgA: Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgG, Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgA

时间窗: 6 to 10 months from study initiation

Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off

时间窗: 6 to 10 months from study initiation

Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off

时间窗: 6 to 10 months from study initiation

次要结局

  • Difference in HAV, VZV, CMV , HSV and BP seropositivity rates according to socioeconomic status, age group, gender, region, risk group, area and pertussis vaccination status (only for BP analysis)(6 to 10 months from study initiation)

研究者

申办方类型
Industry

研究点 (1)

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