Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis

Completed

• Conditions: Cytomegalovirus; Varicella-Zoster Virus; Hepatitis A; Herpes Simplex (1 and 2); Viral Hepatitis Vaccines; Bordetella Pertussis Infection
• Interventions: Other: Serum sample

• Registration Number: NCT01160081
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-11
• Last Update Submitted: 2011-01-22
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3658

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
National Health and Nutrition Survey 2006 (ENSANUT 2006)	Serum sample	-

Primary Outcome Measures

Name	Time	Method
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	6 to 10 months from study initiation
Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.	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	6 to 10 months from study initiation
Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off	6 to 10 months from study initiation
Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off	6 to 10 months from study initiation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇲🇽 Cuernavaca, Morelos, Mexico