Skip to main content
OpenTrials
Completed

NCT Number: NCT01160081

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Viral Hepatitis Vaccines Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Bordetella Pertussis Infection Chickenpox Cytomegalovirus DNA Virus Infections Digestive System Diseases Enterovirus Infections Gram-Negative Bacterial Infections Hepatitis Hepatitis A Hepatitis, Viral, Human Herpes Simplex Herpes Simplex (1 and 2) Herpesviridae Infections Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Varicella Zoster Virus Infection Varicella-zoster Virus Virus Diseases Whooping Cough

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Cuernavaca, Morelos, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum sample

Other

Serum samples collected

Primary outcomes

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

    Time frame: 6 to 10 months from study initiation

  2. 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

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

    Time frame: 6 to 10 months from study initiation

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

    Time frame: 6 to 10 months from study initiation

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 12, 2010
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.