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

NCT ID: NCT02112890

Last Updated: 2019-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1603 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-10

Study Completion Date

2016-05-02

Brief Summary

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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

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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.

Conditions

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Hepatitis A Viral Hepatitis Vaccines

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study Group

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

Data collection

Intervention Type OTHER

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.

Interventions

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Data collection

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Cuernavaca, Morelos, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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201076

Identifier Type: -

Identifier Source: org_study_id

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