Clinical trial NCT01160081: Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
Official title: Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Hepatitis Vaccines
Hepatitis A
Cytomegalovirus
Varicella-Zoster Virus
Bordetella Pertussis Infection
Herpes Simplex (1 and 2)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 3658
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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).

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.

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 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.

Primary outcomes:
measure: Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.
timeFrame: 6 to 10 months from study initiation
measure: 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
timeFrame: 6 to 10 months from study initiation
measure: Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off
timeFrame: 6 to 10 months from study initiation
measure: Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off
timeFrame: 6 to 10 months from study initiation
measure: 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
timeFrame: 6 to 10 months from study initiation
Secondary outcomes:
measure: 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)
timeFrame: 6 to 10 months from study initiation
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: