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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT02112890

Collaborator

(none)

1,603

Enrollment

Location

16.7

Actual Duration (Months)

95.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A Viral Hepatitis Vaccines	Other: Data collection

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 Design

Study Type:

Observational

Actual Enrollment :

1603 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

Actual Study Start Date :

Dec 10, 2014

Actual Primary Completion Date :

May 2, 2016

Actual Study Completion Date :

May 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.

Arm

Intervention/Treatment

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.