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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160081
First received: July 8, 2010
Last updated: January 22, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Viral Hepatitis Vaccines
Hepatitis A
Cytomegalovirus
Varicella-Zoster Virus
Bordetella Pertussis Infection
Herpes Simplex (1 and 2)
 Other: Serum sample

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off. [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum samples


Enrollment: 3658
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
National Health and Nutrition Survey 2006 (ENSANUT 2006) Other: Serum sample
Serum samples collected

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.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160081

Locations
Mexico
GSK Investigational Site
Cuernavaca, Morelos, Mexico
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01160081     History of Changes
Other Study ID Numbers: 113564
Study First Received: July 8, 2010
Last Updated: January 22, 2011
Health Authority: Mexico: Secretaría de Salud

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Hepatitis
Hepatitis A
Herpes Simplex
Whooping Cough
Hepatitis C
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013