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

January 22, 2011 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include a random sample of 4000 subjects of subjects who participated in the 2006 National Health and Nutrition Survey (ENSANUT).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
National Health and Nutrition Survey 2006 (ENSANUT 2006)
Other: Serum sample
Serum samples collected

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 6 to 10 months from study initiation
6 to 10 months from study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 22, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113564

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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