Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

GlaxoSmithKline1,603 enrolled

Overview

This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.

A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) will be selected from the total population that participated in the Encuesta Nacional de Salud y Nutrición (ENSANUT) 2012 in Mexico. Data (through structured questionnaires and interviews) and stored serum samples of the selected subjects obtained from the ENSANUT 2012 will be used in this study. A subset database will be designed by the National Institute of Public Health (NIPH) for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in this database.

Study Type

OBSERVATIONAL

Enrollment

1,603

Conditions

Hepatitis A Viral Hepatitis Vaccines

Interventions

Data collectionOTHER

Data of the selected subjects (through structured questionnaires and interviews) and stored serum samples obtained from the ENSANUT 2012. A subset database will be designed by the NIPH for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in the study database.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent for the ENSANUT 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (LAR) of the subject. * A male or female between and including 10 and 25 years of age, who previously participated in the ENSANUT 2012 in Mexico. Exclusion Criteria: * Information required for the study is not available or incomplete. * Inadequate or insufficient serum sample to perform the laboratory tests for this study. * Serum sample is wrongly identified.

Locations (1)

GSK Investigational Site

Cuernavaca, Morelos, Mexico

Outcomes

Primary Outcomes

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV

Time frame: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HBV (Hepatitis B core antibody [anti-HBc], Hepatitis B surface antigen [HBsAg]) and Hepatitis B surface antibody (anti-HBs)

Time frame: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies

Time frame: During the study (approximately 12 months)

Secondary Outcomes

Assesment of the difference in HAV, HBV and B. pertussis seropositivity rates among - Socioeconomic strata, - Regions, - Age groups, - Genders, - Risk groups, - Vaccination status for B. pertussis (if available)

Time frame: During the study (approximately 12 months)

Data from ClinicalTrials.gov

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