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

Hepatitis A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160081
• Other study ID #: 113564
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: January 22, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaría de Salud
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3658
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bordetella Pertussis Infection
• Chickenpox
• Cytomegalovirus
• Hepatitis
• Hepatitis A
• Herpes Simplex
• Herpes Simplex (1 and 2)
• Herpes Zoster
• Varicella-Zoster Virus
• Viral Hepatitis Vaccines
• Whooping Cough

Intervention

Other:
• Serum sample
Serum samples collected

Locations

Country	Name	City	State
Mexico	GSK Investigational Site	Cuernavaca	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.		6 to 10 months from study initiation	No
Primary	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	No
Primary	Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off		6 to 10 months from study initiation	No
Primary	Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off		6 to 10 months from study initiation	No
Primary	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	No
Secondary	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	No