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

Completed

• Conditions: Viral Hepatitis Vaccines; Hepatitis A
• Interventions: Other: Data collection

• Registration Number: NCT02112890
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Study Start: 2014-12-10
• Primary Completion: 2016-05-02
• Study Completion: 2016-05-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1603

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Data collection	A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) that participated in the ENSANUT 2012 in Mexico.

Primary Outcome Measures

Name	Time	Method
Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV	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)	During the study (approximately 12 months)
Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies	During the study (approximately 12 months)

Secondary Outcome Measures

Name	Time	Method
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)	During the study (approximately 12 months)

Trial Locations

Locations (1)

GSK Investigational Site; 🇲🇽 Cuernavaca, Morelos, Mexico