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

NCT01160081 | Completed

• 1 other identifier: 113564
• Study Type: observational
• Target: 3,658
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Hepatitis Vaccines; Hepatitis A; Cytomegalovirus; Varicella-Zoster Virus; Bordetella Pertussis Infection; Herpes Simplex (1 and 2)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

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)

  6 to 10 months from study initiation

Study Arms (1)

National Health and Nutrition Survey 2006 (ENSANUT 2006)

Other: Serum sample

Interventions

Serum sample OTHER

Serum samples collected

National Health and Nutrition Survey 2006 (ENSANUT 2006)

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cuernavaca, Morelos, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

MeSH Terms

Conditions

Hepatitis A; Chickenpox; Whooping Cough; Herpes Simplex

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 25, 2011

Record last verified: 2010-11

Locations

ME (1)